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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin

    Summary
    EudraCT number
    2014-000914-76
    Trial protocol
    CZ   HU   IT   ES   DE   PL   RO   HR   LV   BG  
    Global end of trial date
    16 Aug 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Sep 2017
    First version publication date
    02 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1409R2121
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02321800
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shionogi Inc.
    Sponsor organisation address
    300 Campus Drive, Florham Park, United States, NJ 07932
    Public contact
    Simon Portsmouth, MD FRCP, Shionogi Inc., +1 973 307 3901, simon.portsmouth@shionogi.com
    Scientific contact
    Simon Portsmouth, MD FRCP, Shionogi Inc., +1 973 307 3901, simon.portsmouth@shionogi.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
    22 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the composite outcome of microbiological eradication and clinical response of cefiderocol with that of imipenem/cilastatin (IPM/CS) in a subject population at risk for multidrug resistant (MDR) Gram-negative pathogens originating from complicated urinary tract infections (cUTIs) with or without pyelonephritis or acute uncomplicated pyelonephritis. The primary efficacy assessment was performed at the Test of Cure (TOC) (approximately 7 days following the End of Treatment [EOT]); (EOT is defined as the last day of study drug treatment).
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. The rational of the study, procedural details, and investigational goals were explained to each subject, along with potential risks and benefits. Each subject was assured of his/her right to withdraw from the study at any time.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Feb 2015
    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
    Poland: 71
    Country: Number of subjects enrolled
    Romania: 112
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Croatia: 39
    Country: Number of subjects enrolled
    Bulgaria: 23
    Country: Number of subjects enrolled
    Czech Republic: 37
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 26
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Latvia: 11
    Country: Number of subjects enrolled
    Russian Federation: 74
    Country: Number of subjects enrolled
    Georgia: 20
    Country: Number of subjects enrolled
    Japan: 15
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    452
    EEA total number of subjects
    336
    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)
    214
    From 65 to 84 years
    226
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The screening period consists of the two days prior randomisation. Eligibility criteria were reviewed and qualified subjects providing informed consent entered the study.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    cefiderocol
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    cefiderocol
    Investigational medicinal product code
    S-649266
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2000 mg intravenously every 8 hours (6 or 8 hours based on renal function and/or body weight) for a period of 7 to 14 days.

    Arm title
    imipenem/cilastatin
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    imipenem/cilastatin (1000mg)
    Investigational medicinal product code
    IPM/CS 1000mg
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg intravenously every 8 hours (6 or 8 hours based on renal function and/or body weight) for a period of 7 to 14 days.

    Number of subjects in period 1
    cefiderocol imipenem/cilastatin
    Started
    303
    149
    Completed
    283
    138
    Not completed
    20
    11
         Randomized but not treated
    3
    1
         Protocol deviation
    1
    -
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    2
    3
         Consent withdrawn by subject
    3
    3
         Lost to follow-up
    10
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    cefiderocol
    Reporting group description
    -

    Reporting group title
    imipenem/cilastatin
    Reporting group description
    -

    Reporting group values
    cefiderocol imipenem/cilastatin Total
    Number of subjects
    303 149 452
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    144 70 214
        From 65-84 years
    153 73 226
        85 years and over
    6 6 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.2 ± 16.5 61.4 ± 17.8 -
    Gender categorical
    Units: Subjects
        Female
    165 83 248
        Male
    138 66 204

    End points

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    End points reporting groups
    Reporting group title
    cefiderocol
    Reporting group description
    -

    Reporting group title
    imipenem/cilastatin
    Reporting group description
    -

    Subject analysis set title
    mITT Population (cefiderocol )
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All ITT patients who have a baseline Gram-negative bacterial uropathogen on culture of urine or blood that causes UTI and have received the study drug cefiderocol. Patients should not be excluded from this population based upon events that occurred post randomization (eg, loss to follow-up).

    Subject analysis set title
    mITT Population (IPM/CS)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All ITT patients who have a baseline Gram-negative bacterial uropathogen on culture of urine or blood that causes UTI and have received the active comparator IPM/CS. Patients should not be excluded from this population based upon events that occurred post randomization (eg, loss to follow-up).

    Primary: Composite of clinical outcome and microbiological outcome at TOC

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    End point title
    Composite of clinical outcome and microbiological outcome at TOC
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Test of Cure (TOC)
    End point values
    mITT Population (cefiderocol ) mITT Population (IPM/CS)
    Number of subjects analysed
    252
    119
    Units: Proportion of responders
        number (not applicable)
    183
    65
    Statistical analysis title
    Proportion of Responders
    Comparison groups
    mITT Population (cefiderocol ) v mITT Population (IPM/CS)
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Proportion difference
    Point estimate
    18.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.23
         upper limit
    28.92

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of informed consent through 28 days (± 3 days) after the last dose of the study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    cefiderocol
    Reporting group description
    -

    Reporting group title
    Imipenem/Cilastatin
    Reporting group description
    -

    Serious adverse events
    cefiderocol Imipenem/Cilastatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 300 (4.67%)
    12 / 148 (8.11%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Urethrotomy
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (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
    Pyrexia
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal injury
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocrit decreased
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital ureteric anomaly
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder pain
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive nephropathy
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (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
    Abscess
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 148 (1.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic abscess
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 148 (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 / 300 (0.33%)
    0 / 148 (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: 2%
    Non-serious adverse events
    cefiderocol Imipenem/Cilastatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    118 / 300 (39.33%)
    72 / 148 (48.65%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 300 (4.33%)
    8 / 148 (5.41%)
         occurrences all number
    13
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 300 (2.33%)
    1 / 148 (0.68%)
         occurrences all number
    7
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 300 (2.33%)
    8 / 148 (5.41%)
         occurrences all number
    7
    8
    General disorders and administration site conditions
    Infusion site erythema
         subjects affected / exposed
    3 / 300 (1.00%)
    3 / 148 (2.03%)
         occurrences all number
    3
    3
    Infusion site pain
         subjects affected / exposed
    9 / 300 (3.00%)
    5 / 148 (3.38%)
         occurrences all number
    9
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 300 (1.33%)
    3 / 148 (2.03%)
         occurrences all number
    4
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 300 (0.67%)
    5 / 148 (3.38%)
         occurrences all number
    2
    5
    Constipation
         subjects affected / exposed
    10 / 300 (3.33%)
    6 / 148 (4.05%)
         occurrences all number
    10
    6
    Diarrhoea
         subjects affected / exposed
    12 / 300 (4.00%)
    8 / 148 (5.41%)
         occurrences all number
    12
    8
    Nausea
         subjects affected / exposed
    7 / 300 (2.33%)
    6 / 148 (4.05%)
         occurrences all number
    7
    6
    Vomiting
         subjects affected / exposed
    6 / 300 (2.00%)
    2 / 148 (1.35%)
         occurrences all number
    6
    2
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    4 / 300 (1.33%)
    5 / 148 (3.38%)
         occurrences all number
    4
    5
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    5 / 300 (1.67%)
    4 / 148 (2.70%)
         occurrences all number
    5
    4
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 300 (0.00%)
    3 / 148 (2.03%)
         occurrences all number
    0
    3
    Vaginal infection
         subjects affected / exposed
    1 / 300 (0.33%)
    3 / 148 (2.03%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Aug 2015
    •Modified wording describing the primary objective, clarifying that the primary comparison is a composite outcome and not clinical or microbiological responses individually •Clarified subject population (including restriction/stratification of subjects with uncomplicated pyelonephritis, number of pathogens that could be present in urine), duration of treatment, dose adjustment (based on Cockcroft-Gault equation) •Clarified period during which women should not attempt to get pregnant after study drug administration and also allowed for country specific requirements, which might be longer •Clarified “the what and the why” for prohibited medications •Clarified components of clinical evaluation and microbiological response •Clarified statistical section, incorporated 15% noninferiority margin, defined populations, clarified sample size, and clarified stratification at randomization •Clarified function of the DSMB as performing a safety evaluation and not an interim analysis of efficacy •Clarified that treatment duration of 7 to 14 days in hospital may be shortened to 5 days if it became in the subject’s best interest •Clarified minimum versus recommended treatment duration •Adjusted dosing tables to include dosing instructions for subjects weighing <40kg •Clarified the need to record all concomitant antimicrobial therapies and time frame involved, and reinforced that the use of antimicrobial therapies with only Gram-positive activities were allowed if needed; clarified timing for withdrawal and restarting these therapies in relation to treatment; added details for use of rescue therapy and prophylactic antimicrobials •Added Subject Structured Interview and changed terminology to “Structured Patient Interview” for consistency •Clarified definition of AEs in the context of study, study treatment, and population •Clarified follow-up time for SAEs, reporting time for pregnancy, and reasons for discontinuation •Specified timing of ECG in relation to infusion
    30 Nov 2015
    • Increased the number of subjects (from 300 to 400) so that this study would provide the majority of subjects for the safety evaluation of the drug for the submission to the FDA • Increased the number of subjects with acute uncomplicated pyelonephritis and the time required for enrollment and revised statistical evaluation description • Allowed for collection of available safety laboratory information that may have been available prior to the subject entering the study, ie, prior to any drug treatment for subjects with previous short term antibiotic treatment (< 24 hours) • Clarified what needed to be completed in the event that a super infection or a new infection was identified • Clarified the primary analysis and the method of arriving at the result
    26 Apr 2016
    • Increased the number of subjects (from 400 to 450) so that this study would provide sufficient safety subjects for submission to the FDA (for a total of 300 subjects treated with cefiderocol) • Increased the number of subjects with acute uncomplicated pyelonephritis and the time required for enrollment and revised statistical evaluation description

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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