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    Clinical Trial Results:
    A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of Complicated Urinary Tract Infection (cUTI), including Acute Pyelonephritis (AP), in Adults

    Summary
    EudraCT number
    		 2015-001588-37
    Trial protocol
    		 EE   LV   CZ   BG   PL   ES   DE   HU  
    Global end of trial date
    22 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACHN-490-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02486627
    WHO universal trial number (UTN)
    		 U1111-1171-1554
    Sponsors
    Sponsor organisation name
    Achaogen Inc.
    Sponsor organisation address
    1 Tower Pl #300,, South San Francisco, United States, 94080
    Public contact
    Clinical Trials Registration Group, Achaogen, Inc., clinical-trials@achaogen.com
    Scientific contact
    Clinical Trials Registration Group, Achaogen, Inc., clinical-trials@achaogen.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 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate the non-inferiority (NI) of plazomicin compared with meropenem based on the difference in composite microbiological eradication and clinical cure rate.
    Protection of trial subjects
    This study was conducted in accordance with the US Food and Drug Administration (FDA) regulations, the International Council on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice (GCP), the Declaration of Helsinki (October 1996), and applicable local, state, national laws. For European Union member states, this included Directive 2001/20/EC, Directive 2005/28/EC, and other directives as applicable as well as applicable local and national laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jan 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 55
    Country: Number of subjects enrolled
    Romania: 73
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Bulgaria: 80
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    Estonia: 51
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Latvia: 57
    Country: Number of subjects enrolled
    Georgia: 81
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Russian Federation: 79
    Country: Number of subjects enrolled
    Serbia: 23
    Country: Number of subjects enrolled
    Ukraine: 72
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    609
    EEA total number of subjects
    349
    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)
    326
    From 65 to 84 years
    271
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 640 subjects were screened and 609 were randomized.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Plazomicin
    Arm description
    		 Subjects received up to 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plazomicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg as a 30 minute (plus or minus 10 minutes) intravenous (IV) infusion once daily. Dose adjustments, including adjustment of dosing schedule, were required based on renal function.

    Investigational medicinal product name
    Levofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 or 500 mg once daily depending on renal function to complete a total of 7 to 10 days of IV plus oral therapy

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Saline placebo administered as a 30 minute (plus or minus 10 minutes) intravenous (IV) infusion 8 and 16 hours post plazomicin infusion. Dose adjustments, including adjustment of dosing schedule, were required based on renal function.

    Arm title
    		 Meropenem
    Arm description
    		 Subjects received 1.0 g meropenem as an intravenous (IV) infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.0 g as a 30 minute (plus or minus 10 minutes) intravenous (IV) infusion every 8 hours (q8h). Dosing schedule adjustments were required based on renal function.

    Investigational medicinal product name
    Levofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 or 500 mg once daily depending on renal function to complete a total of 7 to 10 days of IV plus oral therapy

    Number of subjects in period 1
    		Plazomicin Meropenem
    Started
    306
    303
    Completed
    299
    294
    Not completed
    7
    9
         Consent withdrawn by subject
    4
    3
         Death
    1
    -
         Other
    -
    2
         Significant patient noncompliance
    1
    1
         Lost to follow-up
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Plazomicin
    Reporting group description
    		 Subjects received up to 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

    Reporting group title
    Meropenem
    Reporting group description
    		 Subjects received 1.0 g meropenem as an intravenous (IV) infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

    Reporting group values
    		 Plazomicin Meropenem Total
    Number of subjects
    		 306 303 609
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 168 158 326
        From 65-84 years
    		 134 137 271
        85 years and over
    		 4 8 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.2 ( 18.29 ) 59 ( 17.62 ) -
    Gender categorical
    Units: Subjects
        Female
    		 171 149 320
        Male
    		 135 154 289

    End points

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    End points reporting groups
    Reporting group title
    Plazomicin
    Reporting group description
    		 Subjects received up to 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

    Reporting group title
    Meropenem
    Reporting group description
    		 Subjects received 1.0 g meropenem as an intravenous (IV) infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, subjects could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

    Primary: Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiological Modified Intent to Treat (mMITT) Population at Day 5

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    End point title
    		 Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiological Modified Intent to Treat (mMITT) Population at Day 5
    End point description
    Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at >=10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure at Day 5: marked improvement evidenced by complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms developed. Failure: Lack of improvement in core baseline symptoms of complicated urinary tract infection (cUTI) or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason. The mMTT population subjects received any amount of study drug, had one qualified baseline pathogen where meropenem and plazomicin have antibacterial activity, and no pathogens where they do not have activity.
    End point type
    Primary
    End point timeframe
    Day 5
    End point values
    		 Plazomicin Meropenem
    Number of subjects analysed
    191
    197
    Units: Percentage of Subjects
    number (not applicable)
        Composite Cure
    88
    91.4
        Composite Failure
    10.5
    7.6
        Indeterminate
    1.6
    1
    Statistical analysis title
    		 Plazomicin vs Meropenem
    Statistical analysis description
    95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.
    Comparison groups
    Plazomicin v Meropenem
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 3.1

    Primary: Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiological Modified Intent to Treat (mMITT) Population at Test of Cure (TOC)

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    End point title
    		 Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiological Modified Intent to Treat (mMITT) Population at Test of Cure (TOC)
    End point description
    Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at >=10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure at TOC Visit: the complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason. The mMTT population subjects received any amount of study drug, had one qualified baseline pathogen where meropenem and plazomicin have antibacterial activity, and no pathogens where they do not have activity.
    End point type
    Primary
    End point timeframe
    Day 17 TOC Visit
    End point values
    		 Plazomicin Meropenem
    Number of subjects analysed
    191
    197
    Units: Percentage of Subjects
    number (not applicable)
        Composite Cure
    81.7
    70.1
        Composite Failure
    15.2
    25.9
        Indeterminate
    3.1
    4.1
    Statistical analysis title
    		 Plazomicin vs Meropenem
    Statistical analysis description
    95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.
    Comparison groups
    Meropenem v Plazomicin
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    11.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 20.3

    Secondary: Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiologically Evaluable (ME) Population at Day 5

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    End point title
    		 Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiologically Evaluable (ME) Population at Day 5
    End point description
    Microbiological eradication: urine culture showed the pathogen found at baseline at >=10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure Day 5: Marked improvement defined as complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms develop. Failure Day 5: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the subject required alternative non-study antibiotic therapy for the current cUTI. ME population: clinically evaluable subjects with interpretable culture results, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.
    End point type
    Secondary
    End point timeframe
    Day 5
    End point values
    		 Plazomicin Meropenem
    Number of subjects analysed
    188
    190
    Units: Percentage of Subjects
    number (not applicable)
        Day 5: Composite Cure
    89.4
    94.2
        Day 5: Composite Failure
    10.6
    5.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)

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    End point title
    		 Percentage of Subjects with a Composite Microbiological Eradication and Clinical Cure in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)
    End point description
    Microbiological eradication: urine culture showed the pathogen found at baseline at >=10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure TOC: Complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure TOC: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI.
    End point type
    Secondary
    End point timeframe
    Day 17 TOC Visit
    End point values
    		 Plazomicin Meropenem
    Number of subjects analysed
    179
    177
    Units: Percentage of Subjects
    number (not applicable)
        TOC: Composite Cure
    84.9
    75.1
        TOC: Composite Failure
    15.1
    24.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects with Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the subject was enrolled in the study. The safety population included all randomised subjects who received any amount of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Day 32
    End point values
    		 Plazomicin Meropenem
    Number of subjects analysed
    303
    301
    Units: Percentage of Subjects
        number (not applicable)
    19.5
    21.6
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics (PK): Area Under the Curve from 0 to 24 Hours (AUC 0–24h)

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    End point title
    		 Plasma Pharmacokinetics (PK): Area Under the Curve from 0 to 24 Hours (AUC 0–24h) [1]
    End point description
    PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients. The PK Population included subjects who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.
    End point type
    Secondary
    End point timeframe
    Day 3
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for the meropenem arm are not presented here as PK sample collection does not apply to and was not collected for subjects in the meropenem arm, as only plazomicin levels were measured.
    End point values
    		 Plazomicin
    Number of subjects analysed
    281
    Units: mg * h/L
        geometric mean (geometric coefficient of variation)
    234 ( 38.5 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax)

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    End point title
    		 Plasma Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) [2]
    End point description
    PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients. The PK Population included subjects who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.
    End point type
    Secondary
    End point timeframe
    Day 3
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for the meropenem arm are not presented here as PK sample collection does not apply to and was not collected for subjects in the meropenem arm, as only plazomicin levels were measured.
    End point values
    		 Plazomicin
    Number of subjects analysed
    281
    Units: mg/L
        geometric mean (geometric coefficient of variation)
    46.6 ( 43 )
    No statistical analyses for this end point

    Secondary: Plasma Pharmacokinetics (PK): Minimum Observed Plasma Drug Concentration (Cmin)

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    End point title
    		 Plasma Pharmacokinetics (PK): Minimum Observed Plasma Drug Concentration (Cmin) [3]
    End point description
    PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients. The PK Population included subjects who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.
    End point type
    Secondary
    End point timeframe
    Day 3
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for the meropenem arm are not presented here as PK sample collection does not apply to and was not collected for subjects in the meropenem arm, as only plazomicin levels were measured.
    End point values
    		 Plazomicin
    Number of subjects analysed
    281
    Units: mg/L
        geometric mean (geometric coefficient of variation)
    0.88 ( 95.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 32
    Adverse event reporting additional description
    The AE collection period began with the first dose of study drug and ended at the last follow up visit (LFU). LFU was up to 32 Days after the first dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Plazomicin
    Reporting group description
    		 -

    Reporting group title
    Meropenem
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious treatment-emergent adverse events in >=5% of patients in any treatment group.
    Serious adverse events
    		 Plazomicin Meropenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 303 (1.65%)
    5 / 301 (1.66%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic neoplasm
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 303 (0.66%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 301 (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
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         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 / 303 (0.33%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 301 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 301 (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: 5%
    Non-serious adverse events
    		 Plazomicin Meropenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 303 (0.00%)
    0 / 301 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2015
    The protocol ACHN-490-009 was amended to allow for the inclusion of subjects with moderate renal impairment, defined as a creatinine clearance (CLcr) of >30 to <=60 mL/min as estimated by the Cockcroft-Gault equation. Additional modifications to the protocol were made to better clarify the intent of the existing language in the original protocol.

    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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