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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

    Summary
    EudraCT number
    2010-023452-87
    Trial protocol
    DE   HU   SK   LV   EE   RO  
    Global end of trial date
    04 Sep 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    06 May 2016
    First version publication date
    05 Aug 2015
    Other versions
    v1
    Version creation reason
    • Changes to summary attachments
    Adding attachment which contains a clarifying statement regarding sister study results.
    Summary report(s)
    statement regarding sister study results

    Trial information

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    Trial identification
    Sponsor protocol code
    CXA-cUTI-10-04 and CXA-cUTI-10-05
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01345929
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Cubist Pharmaceuticals, Inc.
    Sponsor organisation address
    65 Hayden Avenue, Lexington, United States,
    Public contact
    Study Director, Cubist Pharmaceuticals, Inc., 1 7818608660,
    Scientific contact
    Study Director, Cubist Pharmaceuticals, Inc., 1 7818608660,
    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
    04 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 intravenous (IV) infusions (1500 milligrams [mg] total, including 1000 mg ceftolozane and 500 mg tazobactam, every 8 hours [q8h]) versus levofloxacin IV infusions (750 mg once a day [qd]) for the treatment of adults with a complicated urinary tract infection (cUTI; including pyelonephritis). Two Phase 3 protocols were initiated (CXA-cUTI-10-04 and CXA-cUTI-10-05). Then, Cubist and the FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 1083 subjects were enrolled: 558 to CXA-cUTI-10-04 and 525 to CXA-cUTI-10-05. Of these, 552 and 516 received treatment. One subject’s age was unknown after enrollment, so this subject is counted in the “Adults (18-64 years)” age category for the purpose of this report.
    Protection of trial subjects
    This study was conducted in compliance with institutional review board (IRB)/independent ethics committee (IEC) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, in accordance with applicable regulations regarding clinical safety data management (E2A, E2B R3), with ICH guidelines regarding scientific integrity (E4, E8, E9, and E10), and with guidelines of local regulatory agencies. In addition, this study adhered to all local regulatory requirements, and requirements for data protection.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 17
    Country: Number of subjects enrolled
    Bulgaria: 15
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Colombia: 41
    Country: Number of subjects enrolled
    Croatia: 12
    Country: Number of subjects enrolled
    Estonia: 27
    Country: Number of subjects enrolled
    Georgia: 60
    Country: Number of subjects enrolled
    Hungary: 71
    Country: Number of subjects enrolled
    India: 38
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Latvia: 53
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Moldova, Republic of: 17
    Country: Number of subjects enrolled
    Peru: 32
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Poland: 77
    Country: Number of subjects enrolled
    Romania: 115
    Country: Number of subjects enrolled
    Russian Federation: 188
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Slovenia: 7
    Country: Number of subjects enrolled
    South Africa: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 16
    Country: Number of subjects enrolled
    Thailand: 39
    Country: Number of subjects enrolled
    Ukraine: 160
    Country: Number of subjects enrolled
    United States: 23
    Worldwide total number of subjects
    1083
    EEA total number of subjects
    382
    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)
    802
    From 65 to 84 years
    261
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects enrolled in this study were at least 18 years of age with a complicated urinary tract infection. Subjects were eligible to participate in the study if they met all of the inclusion criteria and none of the exclusion criteria at the Screening visit.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CXA-201 as treatment for cUTI
    Arm description
    CXA-201 IV infusion (1000 mg of ceftolozane and 500 mg of tazobactam) every 8 hours for 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    CXA-201
    Investigational medicinal product code
    Other name
    Ceftolozane/Tazobactam
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg (1000 mg of ceftolozane and 500 mg of tazobactam) every 8 hours for 7 days

    Arm title
    Levofloxacin as treatment for cUTI
    Arm description
    Levofloxacin IV infusion (750 mg qd) for 7 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    levofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    750 mg once daily for 7 days

    Number of subjects in period 1
    CXA-201 as treatment for cUTI Levofloxacin as treatment for cUTI
    Started
    543
    540
    Completed
    513
    515
    Not completed
    30
    25
         Lack of Informed Consent
    1
    -
         Not specified
    7
    4
         Adverse event, non-fatal
    -
    1
         Consent withdrawn by subject
    13
    10
         Lost to follow-up
    9
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CXA-201 as treatment for cUTI
    Reporting group description
    CXA-201 IV infusion (1000 mg of ceftolozane and 500 mg of tazobactam) every 8 hours for 7 days.

    Reporting group title
    Levofloxacin as treatment for cUTI
    Reporting group description
    Levofloxacin IV infusion (750 mg qd) for 7 days.

    Reporting group values
    CXA-201 as treatment for cUTI Levofloxacin as treatment for cUTI Total
    Number of subjects
    543 540
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    49.8 ± 19.6 48.7 ± 20.1 -
    Gender, Male/Female
    Units: participants
        Female
    0
        Male
    0
    Subject analysis sets

    Subject analysis set title
    CXA-201 as treatment for cUTI - Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received any amount of the study drug. Subjects in the Safety population were categorised based on the actual treatment that the subjects received, irrespective of the treatment to which they were randomised.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received any amount of the study drug. Subjects in the Safety population were categorised based on the actual treatment that the subjects received, irrespective of the treatment to which they were randomised.

    Subject analysis set title
    CXA-201 as treatment for cUTI - ME Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiologically evaluable (ME) population is a subset of the clinically evaluable (CE) population who adhered to study procedures and had an appropriately collected urine culture specimen and interpretable urine culture result at the TOC visit. The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - ME Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiologically evaluable (ME) population is a subset of the clinically evaluable (CE) population who adhered to study procedures and had an appropriately collected urine culture specimen and interpretable urine culture result at the TOC visit. The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    CXA-201 as treatment for cUTI - mMITT Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiological modified intent-to-treat (mMITT) population was a subset of the modified intent-to-treat (MITT) population that included subjects who had at least 1 qualified uropathogen from a study-qualifying pretreatment baseline urine specimen. The MITT population consisted of all randomised subjects who received any amount of study drug.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - mMITT Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiological modified intent-to-treat (mMITT) population was a subset of the modified intent-to-treat (MITT) population that included subjects who had at least 1 qualified uropathogen from a study-qualifying pretreatment baseline urine specimen. The MITT population consisted of all randomised subjects who received any amount of study drug.

    Subject analysis sets values
    CXA-201 as treatment for cUTI - Safety Population Levofloxacin as treatment for cUTI - Safety Population CXA-201 as treatment for cUTI - ME Population Levofloxacin as treatment for cUTI - ME Population CXA-201 as treatment for cUTI - mMITT Population Levofloxacin as treatment for cUTI - mMITT Population
    Number of subjects
    533
    535
    340
    353
    398
    402
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Gender, Male/Female
    Units: participants
        Female
    374
    380
        Male
    159
    155

    End points

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    End points reporting groups
    Reporting group title
    CXA-201 as treatment for cUTI
    Reporting group description
    CXA-201 IV infusion (1000 mg of ceftolozane and 500 mg of tazobactam) every 8 hours for 7 days.

    Reporting group title
    Levofloxacin as treatment for cUTI
    Reporting group description
    Levofloxacin IV infusion (750 mg qd) for 7 days.

    Subject analysis set title
    CXA-201 as treatment for cUTI - Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received any amount of the study drug. Subjects in the Safety population were categorised based on the actual treatment that the subjects received, irrespective of the treatment to which they were randomised.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received any amount of the study drug. Subjects in the Safety population were categorised based on the actual treatment that the subjects received, irrespective of the treatment to which they were randomised.

    Subject analysis set title
    CXA-201 as treatment for cUTI - ME Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiologically evaluable (ME) population is a subset of the clinically evaluable (CE) population who adhered to study procedures and had an appropriately collected urine culture specimen and interpretable urine culture result at the TOC visit. The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - ME Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiologically evaluable (ME) population is a subset of the clinically evaluable (CE) population who adhered to study procedures and had an appropriately collected urine culture specimen and interpretable urine culture result at the TOC visit. The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    CXA-201 as treatment for cUTI - mMITT Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiological modified intent-to-treat (mMITT) population was a subset of the modified intent-to-treat (MITT) population that included subjects who had at least 1 qualified uropathogen from a study-qualifying pretreatment baseline urine specimen. The MITT population consisted of all randomised subjects who received any amount of study drug.

    Subject analysis set title
    Levofloxacin as treatment for cUTI - mMITT Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    The microbiological modified intent-to-treat (mMITT) population was a subset of the modified intent-to-treat (MITT) population that included subjects who had at least 1 qualified uropathogen from a study-qualifying pretreatment baseline urine specimen. The MITT population consisted of all randomised subjects who received any amount of study drug.

    Primary: The percentage of subjects who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population

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    End point title
    The percentage of subjects who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population
    End point description
    End point type
    Primary
    End point timeframe
    Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
    End point values
    CXA-201 as treatment for cUTI - ME Population Levofloxacin as treatment for cUTI - ME Population
    Number of subjects analysed
    340
    353
    Units: percentage of subjects
        number (not applicable)
    84.7
    75.4
    Statistical analysis title
    STATISTICAL_ANALYSIS
    Comparison groups
    CXA-201 as treatment for cUTI - ME Population v Levofloxacin as treatment for cUTI - ME Population
    Number of subjects included in analysis
    693
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    9.4
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    1.54
         upper limit
    17.12
    Notes
    [1] - Non-inferiority was concluded if the lower bound of the 2-sided 99% CI was greater than -10%.

    Secondary: The percentage of subjects who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure at the TOC Visit in the microbiological modified intent to-treat (mMITT) population

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    End point title
    The percentage of subjects who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure at the TOC Visit in the microbiological modified intent to-treat (mMITT) population
    End point description
    End point type
    Secondary
    End point timeframe
    Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)
    End point values
    CXA-201 as treatment for cUTI - mMITT Population Levofloxacin as treatment for cUTI - mMITT Population
    Number of subjects analysed
    398
    402
    Units: percentage of subjects
        number (not applicable)
    78.6
    69.9
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    CXA-201 as treatment for cUTI - mMITT Population v Levofloxacin as treatment for cUTI - mMITT Population
    Number of subjects included in analysis
    800
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    Parameter type
    Risk difference (RD)
    Point estimate
    8.7
    Confidence interval
         level
    99%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    16.57
    Notes
    [2] - Non-inferiority was concluded if the lower bound of the 2-sided 99% CI was greater than -10%.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded for all subjects from the start of study drug administration through the last follow up visit, which occurred 28 to 35 days after the last dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Levofloxacin as treatment for cUTI
    Reporting group description
    Levofloxacin IV infusion (750 mg qd) for 7 days

    Reporting group title
    CXA-201 as treatment for cUTI
    Reporting group description
    CXA-201 IV infusion (1500 mg q8) for 7 days

    Serious adverse events
    Levofloxacin as treatment for cUTI CXA-201 as treatment for cUTI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 535 (3.36%)
    15 / 533 (2.81%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (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
    Transient ischaemic attack
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia obstructive
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (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
    Calculus urinary
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysematous pyelonephritis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (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
    6 / 535 (1.12%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 533 (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
    1 / 535 (0.19%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 533 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Levofloxacin as treatment for cUTI CXA-201 as treatment for cUTI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 535 (4.86%)
    31 / 533 (5.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 535 (4.86%)
    31 / 533 (5.82%)
         occurrences all number
    26
    35

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    Two identical protocols were initiated (CXA-cUTI-10-04 and CXA-cUTI-10-05). Then, Cubist and the FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.
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