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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Active-controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis.

    Summary
    EudraCT number
    		 2018-001451-13
    Trial protocol
    		 LV   CZ   HU   BG   HR   RO  
    Global end of trial date
    14 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2023
    First version publication date
    19 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VNRX-5133-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03840148
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Venatorx Pharmaceuticals, Inc.
    Sponsor organisation address
    74 E. Swedesford Road, Suite 100, Malvern, PA, United States, 19355
    Public contact
    Clinical Research, Venatorx Pharmaceuticals, Inc., +1 (610) 644-8935, contact@Venatorx.com
    Scientific contact
    Clinical Research, Venatorx Pharmaceuticals, Inc., +1 (610) 644-8935, contact@Venatorx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of cefepime/VNRX 5133 compared with meropenem with respect to both per patient microbiologic eradication and symptomatic resolution of all urinary tract infection (UTI)-core symptoms (or return to pre morbid baseline) at the Test of Cure (TOC) visit
    Protection of trial subjects
    1. Conducted under Good Clinical Practice (GCP) 2. Ethics Committee/Institutional Review Board approval 3. Informed consent 4. Safety monitoring / DSMB
    Background therapy
    		 None.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 62
    Country: Number of subjects enrolled
    Croatia: 8
    Country: Number of subjects enrolled
    Bulgaria: 153
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Latvia: 57
    Country: Number of subjects enrolled
    United States: 44
    Country: Number of subjects enrolled
    Serbia: 17
    Country: Number of subjects enrolled
    Russian Federation: 76
    Country: Number of subjects enrolled
    Turkey: 27
    Country: Number of subjects enrolled
    Ukraine: 95
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    China: 49
    Country: Number of subjects enrolled
    Mexico: 16
    Country: Number of subjects enrolled
    Peru: 22
    Worldwide total number of subjects
    661
    EEA total number of subjects
    310
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    412
    From 65 to 84 years
    234
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult patients with complicated urinary tract infection, including acute pyelonephritis.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    All study drugs were prepared at the study site by an unblinded pharmacist or designee. Prepared study drug and placebo IV bags and IV tubing were blinded with sleeves to maintain the blind.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cefepime-taniborbactam
    Arm description
    		 Patients randomized to cefepime-taniborbactam received meropenem placebo intravenous (IV) immediately followed by cefepime-taniborbactam (2 g/0.5 g IV q8h). Meropenem placebo was administered via IV pump over 30 minutes. Cefepime-taniborbactam was administered via IV pump over a 2-hour period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cefepime-Taniborbactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2g/cefepime vial and 0.5g/taniborbactam vial individually reconstituted and combined in 250 mL 0.9% sodium chloride IV

    Arm title
    		 Meropenem
    Arm description
    		 Patients randomized to receive meropenem received cefepime-taniborbactam placebo intravenous (IV) immediately following meropenem (1 g IV every 8 hours). Meropenem was infused over 30 minutes. Cefepime-taniborbactam placebo was administered via IV pump over a 2-hour period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 g/vial; reconstituted and added to 50 mL 0.9% sodium chloride

    Number of subjects in period 1
    		Cefepime-taniborbactam Meropenem
    Started
    441
    220
    Completed
    426
    214
    Not completed
    15
    6
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    6
    2
         Physician decision
    2
    -
         COVID-19 related
    2
    -
         Lost to follow-up
    1
    1
         Reason not provided
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cefepime-taniborbactam
    Reporting group description
    		 Patients randomized to cefepime-taniborbactam received meropenem placebo intravenous (IV) immediately followed by cefepime-taniborbactam (2 g/0.5 g IV q8h). Meropenem placebo was administered via IV pump over 30 minutes. Cefepime-taniborbactam was administered via IV pump over a 2-hour period

    Reporting group title
    Meropenem
    Reporting group description
    		 Patients randomized to receive meropenem received cefepime-taniborbactam placebo intravenous (IV) immediately following meropenem (1 g IV every 8 hours). Meropenem was infused over 30 minutes. Cefepime-taniborbactam placebo was administered via IV pump over a 2-hour period.

    Reporting group values
    		 Cefepime-taniborbactam Meropenem Total
    Number of subjects
    		 441 220 661
    Age categorical
    Units: Subjects
        <65 years
    		 275 137 412
        65 to 75 years
    		 111 56 167
        >75 years
    		 55 27 82
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.2 ± 17.43 55.8 ± 18.15 -
    Gender categorical
    Units: Subjects
        Female
    		 248 115 363
        Male
    		 193 105 298
    Subject analysis sets

    Subject analysis set title
    microITT Analysis Population: Cefepime-taniborbactam
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological intent-to-treat (microITT) analysis population consisted of all patients in the intent-to-treat analysis population who: − Had a positive study entry (ie, baseline) urine culture defined as ≥10^5 colony forming unit/mL of a gram-negative pathogen(s) against which both cefepime-taniborbactam and meropenem had antibacterial activity, and − Had no more than 2 microorganisms identified in the study entry (ie, baseline) culture regardless of colony count.

    Subject analysis set title
    microITT analysis population: Meropenem
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological intent-to-treat (microITT) analysis population consisted of all patients in the intent-to-treat analysis population who: − Had a positive study entry (ie, baseline) urine culture defined as ≥10^5 colony forming unit/mL of a gram-negative pathogen(s) against which both cefepime-taniborbactam and meropenem had antibacterial activity, and − Had no more than 2 microorganisms identified in the study entry (ie, baseline) culture regardless of colony count.

    Subject analysis sets values
    		 microITT Analysis Population: Cefepime-taniborbactam microITT analysis population: Meropenem
    Number of subjects
    293
    143
    Age categorical
    Units: Subjects
        <65 years
    180
    90
        65 to 75 years
    72
    35
        >75 years
    41
    18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.5 ± 17.64
    55.8 ± 17.93
    Gender categorical
    Units: Subjects
        Female
    161
    69
        Male
    132
    74

    End points

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    End points reporting groups
    Reporting group title
    Cefepime-taniborbactam
    Reporting group description
    		 Patients randomized to cefepime-taniborbactam received meropenem placebo intravenous (IV) immediately followed by cefepime-taniborbactam (2 g/0.5 g IV q8h). Meropenem placebo was administered via IV pump over 30 minutes. Cefepime-taniborbactam was administered via IV pump over a 2-hour period

    Reporting group title
    Meropenem
    Reporting group description
    		 Patients randomized to receive meropenem received cefepime-taniborbactam placebo intravenous (IV) immediately following meropenem (1 g IV every 8 hours). Meropenem was infused over 30 minutes. Cefepime-taniborbactam placebo was administered via IV pump over a 2-hour period.

    Subject analysis set title
    microITT Analysis Population: Cefepime-taniborbactam
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological intent-to-treat (microITT) analysis population consisted of all patients in the intent-to-treat analysis population who: − Had a positive study entry (ie, baseline) urine culture defined as ≥10^5 colony forming unit/mL of a gram-negative pathogen(s) against which both cefepime-taniborbactam and meropenem had antibacterial activity, and − Had no more than 2 microorganisms identified in the study entry (ie, baseline) culture regardless of colony count.

    Subject analysis set title
    microITT analysis population: Meropenem
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological intent-to-treat (microITT) analysis population consisted of all patients in the intent-to-treat analysis population who: − Had a positive study entry (ie, baseline) urine culture defined as ≥10^5 colony forming unit/mL of a gram-negative pathogen(s) against which both cefepime-taniborbactam and meropenem had antibacterial activity, and − Had no more than 2 microorganisms identified in the study entry (ie, baseline) culture regardless of colony count.

    Primary: Composite (Microbiological and Clinical) Response at Test of Cure

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    End point title
    		 Composite (Microbiological and Clinical) Response at Test of Cure
    End point description
    The primary endpoint was the demonstration of microbiological success (any gram negative bacterial pathogens found at study entry are eradicated to <10^3 colony forming units per milliliter [CFU/mL] on urine culture) and the demonstration of symptomatic clinical success (symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms, no new symptoms, patient is alive, and patient has not received additional antibacterial therapy for cUTI) at TOC in the microbiological intent-to- treat (microITT) population.
    End point type
    Primary
    End point timeframe
    Tested at Test of Cure visit (Day 19 to 23).
    End point values
    		 microITT Analysis Population: Cefepime-taniborbactam microITT analysis population: Meropenem
    Number of subjects analysed
    293
    143
    Units: subjects
        Composite Success
    207
    83
        Composite Failure
    73
    53
        Composite Indeterminate
    13
    7
    Statistical analysis title
    		 Composite Success Response Rate
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0088 [1]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Response Rate Difference
    Point estimate
    12.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 22.2
    Notes
    [1] - P-value for superiority test presented whenever the lower confidence interval is greater than 0 for the primary endpoint analysis

    Secondary: Composite, Microbiological, and Symptomatic Clinical Success at End of Treatment

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    End point title
    		 Composite, Microbiological, and Symptomatic Clinical Success at End of Treatment
    End point description
    Composite Success: The proportion of patients with both microbiological success and symptomatic clinical]success at EOT in the extended microITT population. Microbiological Success: Demonstration that the bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL at EOT in the microITT population. Clinical Success: "Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms patient is alive, and patient has not received additional antibacterial therapy for cUTI) at EOT in the microITT population.
    End point type
    Secondary
    End point timeframe
    End of treatment (within 24 hours after last dose).
    End point values
    		 microITT Analysis Population: Cefepime-taniborbactam microITT analysis population: Meropenem
    Number of subjects analysed
    293
    143
    Units: participants
        Composite Success
    261
    123
        Microbiological Success
    284
    139
        Symptomatic Clinical Success
    265
    127
    Statistical analysis title
    		 Composite Success at End of Treatment
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 10.4
    Statistical analysis title
    		 Microbiological Success at End of Treatment
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 4.1
    Statistical analysis title
    		 Symptomatic Clinical Success at End of Treatment
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 8.5

    Secondary: Composite, Microbiological, and Symptomatic Clinical Success at Late Follow Up

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    End point title
    		 Composite, Microbiological, and Symptomatic Clinical Success at Late Follow Up
    End point description
    Composite Success: The proportion of patients with both microbiological success and symptomatic clinical]success at LFU in the extended microITT population. Microbiological Success: Demonstration that the bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL at LFU in the microITT population. Clinical Success: "Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms patient is alive, and patient has not received additional antibacterial therapy for cUTI) at LFU in the microITT population.
    End point type
    Secondary
    End point timeframe
    Late follow up (Days 28 to 35).
    End point values
    		 microITT Analysis Population: Cefepime-taniborbactam microITT analysis population: Meropenem
    Number of subjects analysed
    293
    143
    Units: participants
        Composite Success
    187
    74
        Microbiological Success
    207
    90
        Symptomatic Clinical Success
    238
    102
    Statistical analysis title
    		 Composite Success at Late Follow Up
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 21.9
    Statistical analysis title
    		 Microbiological Success at Late Follow Up
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT analysis population: Meropenem v microITT Analysis Population: Cefepime-taniborbactam
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 17.3
    Statistical analysis title
    		 Symptomatic Clinical Success at Late Follow Up
    Statistical analysis description
    95% confidence interval of between-treatment differences were based on Miettinen and Nurminen method.
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response Rate Difference
    Point estimate
    9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 18.8

    Secondary: Microbiological and Symptomatic Clinical Success at TOC

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    End point title
    		 Microbiological and Symptomatic Clinical Success at TOC
    End point description
    Microbiological Success: Demonstration that the bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL at TOCin the microITT population. Symptomatic Clinical Success: Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms patient is alive, and patient has not received additional antibacterial therapy for cUTI) at TOC in the microITT population.
    End point type
    Secondary
    End point timeframe
    Tested at Test of Cure visit (Day 19 to 23).
    End point values
    		 microITT Analysis Population: Cefepime-taniborbactam microITT analysis population: Meropenem
    Number of subjects analysed
    293
    143
    Units: participants
        Microbiological Success
    229
    95
        Symptomatic Clinical Success
    251
    116
    Statistical analysis title
    		 Microbiological Success
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0085 [2]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Response rate difference
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 21
    Notes
    [2] - p-value for superiority test presented whenever lower confidence interval is greater than 0.
    Statistical analysis title
    		 Symptomatic Clinical Success
    Comparison groups
    microITT Analysis Population: Cefepime-taniborbactam v microITT analysis population: Meropenem
    Number of subjects included in analysis
    436
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Response rate difference
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 12.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Assessed from screening to late follow-up visit (up to Day 35)
    Adverse event reporting additional description
    Adverse events are presented for the safety analysis population, which consisted of all patients who received any dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cefepime-taniborbactam
    Reporting group description
    		 -

    Reporting group title
    Meropenem
    Reporting group description
    		 -

    Serious adverse events
    		 Cefepime-taniborbactam Meropenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 440 (2.05%)
    4 / 217 (1.84%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 440 (0.00%)
    2 / 217 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubo-ovarian abscess
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cefepime-taniborbactam Meropenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    155 / 440 (35.23%)
    63 / 217 (29.03%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 440 (2.05%)
    2 / 217 (0.92%)
         occurrences all number
    9
    3
    Phlebitis
         subjects affected / exposed
    6 / 440 (1.36%)
    1 / 217 (0.46%)
         occurrences all number
    6
    1
    Hot flush
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Subclavian artery stenosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 440 (1.14%)
    3 / 217 (1.38%)
         occurrences all number
    5
    3
    Chills
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Face oedema
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Generalised oedema
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Infusion site swelling
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Injection site inflammation
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Injection site reaction
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hepatic cyst
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 440 (1.14%)
    2 / 217 (0.92%)
         occurrences all number
    5
    2
    Dyspnoea
         subjects affected / exposed
    4 / 440 (0.91%)
    0 / 217 (0.00%)
         occurrences all number
    4
    0
    Pleural effusion
         subjects affected / exposed
    3 / 440 (0.68%)
    0 / 217 (0.00%)
         occurrences all number
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Catarrh
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Pulmonary mass
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 440 (0.68%)
    2 / 217 (0.92%)
         occurrences all number
    3
    2
    Agitation
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Delirium
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Anxiety
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Confusional state
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Disorientation
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Mental status changes
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Panic attack
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Nightmare
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 440 (0.91%)
    5 / 217 (2.30%)
         occurrences all number
    4
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 440 (0.45%)
    2 / 217 (0.92%)
         occurrences all number
    2
    2
    Human chorionic gonadotropin increased
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Transaminases increased
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Blood creatine increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram change
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Troponin increased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Procedural dizziness
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Angina unstable
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Bundle branch block right
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Angina pectoris
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    27 / 440 (6.14%)
    8 / 217 (3.69%)
         occurrences all number
    27
    8
    Dizziness
         subjects affected / exposed
    7 / 440 (1.59%)
    1 / 217 (0.46%)
         occurrences all number
    7
    2
    Akathisia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Diabetic neuropathy
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Thoracic radiculopathy
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 440 (1.36%)
    3 / 217 (1.38%)
         occurrences all number
    6
    3
    Thrombocytopenia
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Granulocytosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Splenomegaly
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Eye disorders
    Photopsia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 440 (4.09%)
    5 / 217 (2.30%)
         occurrences all number
    21
    5
    Constipation
         subjects affected / exposed
    14 / 440 (3.18%)
    3 / 217 (1.38%)
         occurrences all number
    14
    3
    Nausea
         subjects affected / exposed
    9 / 440 (2.05%)
    2 / 217 (0.92%)
         occurrences all number
    9
    3
    Abdominal distension
         subjects affected / exposed
    7 / 440 (1.59%)
    3 / 217 (1.38%)
         occurrences all number
    7
    3
    Vomiting
         subjects affected / exposed
    6 / 440 (1.36%)
    1 / 217 (0.46%)
         occurrences all number
    7
    1
    Dyspepsia
         subjects affected / exposed
    3 / 440 (0.68%)
    1 / 217 (0.46%)
         occurrences all number
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 440 (0.45%)
    2 / 217 (0.92%)
         occurrences all number
    4
    2
    Gastritis
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Stomatitis
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Colitis
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Diaphragmatic hernia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Enlarged uvula
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Glossitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Pancreatic steatosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Diverticulum intestinal
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Eructation
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Rectal prolapse
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Regurgitation
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Swollen tongue
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Biliary dyskinesia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Cholecystitis acute
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Cholestasis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hepatic lesion
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 440 (0.91%)
    0 / 217 (0.00%)
         occurrences all number
    4
    0
    Rash
         subjects affected / exposed
    3 / 440 (0.68%)
    0 / 217 (0.00%)
         occurrences all number
    3
    0
    Dermatitis allergic
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Urticaria
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Hair growth abnormal
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    3 / 440 (0.68%)
    2 / 217 (0.92%)
         occurrences all number
    3
    2
    Ureteric stenosis
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Acute kidney injury
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Bladder diverticulum
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Diabetic nephropathy
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Nephritis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Nephrosclerosis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Perinephritis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Renal colic
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Urinary tract obstruction
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 440 (0.68%)
    1 / 217 (0.46%)
         occurrences all number
    3
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Neck pain
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Arthralgia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Bone pain
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Bursitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Soft tissue swelling
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 440 (0.00%)
    2 / 217 (0.92%)
         occurrences all number
    0
    2
    Infections and infestations
    Vulvovaginal candidiasis
         subjects affected / exposed
    3 / 440 (0.68%)
    3 / 217 (1.38%)
         occurrences all number
    3
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 440 (0.91%)
    2 / 217 (0.92%)
         occurrences all number
    6
    2
    COVID-19
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    2 / 440 (0.45%)
    1 / 217 (0.46%)
         occurrences all number
    2
    1
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Renal abscess
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Device related bacteraemia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Myringitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Bacteraemia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Mastitis fungal
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Procedural nausea
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 440 (0.45%)
    2 / 217 (0.92%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    7 / 440 (1.59%)
    1 / 217 (0.46%)
         occurrences all number
    9
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 440 (0.45%)
    0 / 217 (0.00%)
         occurrences all number
    2
    0
    Hypoproteinaemia
         subjects affected / exposed
    1 / 440 (0.23%)
    1 / 217 (0.46%)
         occurrences all number
    1
    1
    Dehydration
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hypernatraemia
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Lactose intolerance
         subjects affected / exposed
    1 / 440 (0.23%)
    0 / 217 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 440 (0.00%)
    1 / 217 (0.46%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2019
    • Made clarifications regarding the assessments and procedures required at end of treatment (EOT) when EOT occurred on Study Day 1 • Updated the definitions used for the study endpoints in response to regulatory feedback from the EMA, including a definition of clinical failure that included use of additional antibiotics for the treatment of cUTI that occurred after EOT. • Corrected an error in the collection window at Study Day 3.
    10 Dec 2019
    • Changed unit in Inclusion #4 from cells/μL to cells per high power field • Clarified the primary endpoint and updated the secondary endpoints • Clarified definitions of microbiologically evaluable-End of Treatment, microbiologically evaluable-Test of Cure, and microbiologically evaluable-Late Follow-up populations • Clarified the treatment duration for patients without bacteremia • Added aspartate aminotransferase or alanine aminotransferase ≥10 × upper limit of normal as a potential reason for study drug discontinuation as a result of feedback from the Czech Republic regulatory agency • Revised the definition of success with treatment for asymptomatic bacteremia Added that the race variable African American should only be used for Americans of African descent • Added laboratory abnormalities should be reported as AEs if the result is considered to be clinically significant by the investigator • Added all pregnancies of female clinical study patients or partners of male study patients should be reported to sponsor. Added if written consent was obtained, monitoring of the pregnant patient or partner was to occur • Removed the contract research organization from signature page and replaced with sponsor medical representative.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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