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    Clinical Trial Results:
    A randomized, double-blind, multicenter trial to evaluate the safety and efficacy of sequential (intravenous, oral) moxifloxacin versus comparator in pediatric subjects with complicated intra-abdominal infection

    Summary
    EudraCT number
    		 2009-015578-37
    Trial protocol
    		 DE   ES   LV   LT   CZ   BE   HU   BG   GR   Outside EU/EEA  
    Global end of trial date
    21 Jan 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Jul 2016
    First version publication date
    22 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of results set after re-introduction of EudraCT

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY12-8039/11643
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01069900
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of treatment with moxifloxacin (compared to the safety of intravenous (IV) ertapenem followed by per oral (PO) amoxicillin/clavulanate).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects and/or their legally authorized representative. Participating subjects and/or their legally authorized representative signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 15 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 69
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Lithuania: 25
    Country: Number of subjects enrolled
    Latvia: 88
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Peru: 3
    Country: Number of subjects enrolled
    Romania: 26
    Country: Number of subjects enrolled
    Russian Federation: 10
    Country: Number of subjects enrolled
    Ukraine: 159
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    478
    EEA total number of subjects
    255
    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)
    1
    Children (2-11 years)
    177
    Adolescents (12-17 years)
    300
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at multicenter between 21 July 2010 (first subject first visit) to 21 January 2015 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall 478 subjects were enrolled, 20 subjects had screening failures hence, 458 subjects were randomized to receive treatment.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Moxifloxacin (Avelox, BAY12-8039)
    Arm description
    		 Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Moxifloxacin
    Investigational medicinal product code
    BAY12-8039
    Other name
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    For subjects 12 to less than (<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to < 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to < 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided. Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.

    Arm title
    		 Comparator Ertapenem
    Arm description
    		 Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ertapenem
    Investigational medicinal product code
    Other name
    Invaz
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    For subjects 13 to <18 years of age, the dosage of ertapenem were 1 gram (g) OD. For subjects 3 months to < 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.

    Investigational medicinal product name
    Clavulanate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension and solvent for suspension for injection
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h).

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension and solvent for suspension for injection
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive amoxicillin suspension. The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).

    Number of subjects in period 1 [1]
    		Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Started
    305
    153
    Treated
    301
    150
    Completed
    287
    149
    Not completed
    18
    4
         Consent withdrawn by subject
    6
    1
         Technical problems
    -
    1
         Protocol Violation
    4
    1
         Lost to follow-up
    7
    1
         Insufficient Therapeutic effect
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline period included only the treated subjects. Due to screen failure, not all enrolled subjects were randomized and treated with study drugs.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Moxifloxacin (Avelox, BAY12-8039)
    Reporting group description
    		 Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.

    Reporting group title
    Comparator Ertapenem
    Reporting group description
    		 Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

    Reporting group values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem Total
    Number of subjects
    		 305 153 458
    Age categorical
    Units: Subjects
        12-<18 years
    		 190 94 284
        6-<12 years
    		 100 52 152
        2-<6 years
    		 14 7 21
        3 months - <2 years
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.05 ± 3.66 12.046 ± 3.495 -
    Gender categorical
    Units: Subjects
        Female
    		 124 53 177
        Male
    		 181 100 281
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects (N= 451) treated with at least one dose of study medication.

    Subject analysis sets values
    		 Safety analysis set
    Number of subjects
    451
    Age categorical
    Units: Subjects
        12-<18 years
    278
        6-<12 years
    151
        2-<6 years
    21
        3 months - <2 years
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.038 ± 3.61
    Gender categorical
    Units: Subjects
        Female
    174
        Male
    277

    End points

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    End points reporting groups
    Reporting group title
    Moxifloxacin (Avelox, BAY12-8039)
    Reporting group description
    		 Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.

    Reporting group title
    Comparator Ertapenem
    Reporting group description
    		 Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects (N= 451) treated with at least one dose of study medication.

    Primary: Number of Subjects With Adverse Events

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    End point title
    		 Number of Subjects With Adverse Events [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [2]
    150 [3]
    Units: Subjects
        Any AE
    175
    82
        Any SAE
    20
    6
    Notes
    [2] - Safety analysis set
    [3] - Safety analysis set
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinical Cardiac Adverse Events

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    End point title
    		 Number of Subjects With Clinical Cardiac Adverse Events [4]
    End point description
    End point type
    Primary
    End point timeframe
    All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [5]
    150 [6]
    Units: Subjects
        Any AE
    38
    7
        Any SAE
    0
    0
    Notes
    [5] - Safety analysis set
    [6] - Safety analysis set
    No statistical analyses for this end point

    Primary: Number of Subjects With Musculoskeletal Adverse Events

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    End point title
    		 Number of Subjects With Musculoskeletal Adverse Events [7]
    End point description
    End point type
    Primary
    End point timeframe
    All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [8]
    150 [9]
    Units: Subjects
        Any AE
    13
    5
        Any SAE
    1
    0
    Notes
    [8] - Safety analysis set
    [9] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term

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    End point title
    		 Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
    End point description
    Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.
    End point type
    Secondary
    End point timeframe
    All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [10]
    150 [11]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Forearm fracture
    0.003 (0.0001 to 0.0184)
    0 (0 to 0.0243)
        Joint injury
    0 (0 to 0.0122)
    0.007 (0.0002 to 0.0366)
        Ligament sprain
    0.003 (0.0001 to 0.0184)
    0.007 (0.0002 to 0.0366)
        Muscle strain
    0 (0 to 0.0122)
    0.007 (0.0002 to 0.0366)
        Arthralgia
    0.03 (0.0138 to 0.056)
    0.013 (0.0016 to 0.0473)
        Joint swelling
    0 (0 to 0.0122)
    0.007 (0.0002 to 0.0366)
        Musculoskeletal pain
    0.01 (0.0021 to 0.0288)
    0 (0 to 0.0243)
        Myalgia
    0.003 (0.0001 to 0.0184)
    0 (0 to 0.0243)
    Notes
    [10] - Safety analysis set
    [11] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [12]
    150 [13]
    Units: Beats per minute (bpm)
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 300, 150)
    93.4 ± 19.1
    90.4 ± 16.9
        Change at Day 1 ((N= 294, 148)
    2.8 ± 9.7
    0.3 ± 6.9
        Day 3: Pre-dose (N= 293, 146)
    84.3 ± 17.2
    82.6 ± 16.2
        Change at Day 3 (N= 290, 146)
    1 ± 8.9
    -0.9 ± 7.1
    Notes
    [12] - Safety analysis set
    [13] - Safety analysis set
    No statistical analyses for this end point

    Secondary: PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [14]
    150 [15]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 299, 150)
    136.8294 ± 18.3554
    140.5933 ± 20.5113
        Change at Day 1 ( N= 292, 148)
    0.7123 ± 8.2587
    -0.0203 ± 8.5631
        Day 3: Pre-dose (N= 293, 146)
    139.4915 ± 17.3258
    139.5685 ± 20.8174
        Change at Day 3 (N= 289, 146)
    1.5813 ± 9.2143
    1.5616 ± 9.9322
    Notes
    [14] - Safety analysis set
    [15] - Safety analysis set
    No statistical analyses for this end point

    Secondary: RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    The RR interval refers to the respective time interval in the Electrocardiogram. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [16]
    150 [17]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 300, 150)
    670.7567 ± 142.6153
    689.3067 ± 145.5957
        Change at Day 1 (N= 294, 148)
    -20.6429 ± 74.3401
    -3.4797 ± 56.9955
        Day 3: Pre-dose (N= 293, 146)
    740.4778 ± 149.0964
    754.6027 ± 150.1203
        Change at Day 3 (N= 290, 146)
    -9.2862 ± 77.7582
    10.5137 ± 67.1124
    Notes
    [16] - Safety analysis set
    [17] - Safety analysis set
    No statistical analyses for this end point

    Secondary: QRS Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 QRS Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    The QRS interval represents the time it takes for ventricular depolarization to occur. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [18]
    150 [19]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 300, 150)
    89.0333 ± 7.8279
    88.8067 ± 7.9264
        Change at Day 1 (N= 294, 148)
    0.119 ± 4.3799
    1.223 ± 4.2568
        Day 3: Pre-dose (N= 293, 146)
    89.2423 ± 8.0196
    89.3904 ± 7.8198
        Change at Day 3 (N= 289, 146)
    0.2768 ± 4.123
    0.2877 ± 3.1687
    Notes
    [18] - Safety analysis set
    [19] - Safety analysis set
    No statistical analyses for this end point

    Secondary: QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [20]
    150 [21]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 298, 150)
    341.1812 ± 33.9858
    344.2333 ± 33.5494
        Change at Day 1 (N= 290, 148)
    2.5828 ± 15.213
    1.1149 ± 11.5744
        Day 3: Pre-dose (N= 292, 146)
    358.3082 ± 34.0504
    356.5822 ± 35.6653
        Change at Day 3 (N= 287, 146)
    6.0906 ± 16.1875
    3.1644 ± 11.9586
    Notes
    [20] - Safety analysis set
    [21] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett’s method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [22]
    150 [23]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 298, 150)
    419.5872 ± 19.3278
    417.34 ± 18.5718
        Change at Day 1 (N= 290, 148)
    9.731 ± 14.2961
    2.2905 ± 14.2544
        Day 3: Pre-dose (N= 292, 146)
    419.2055 ± 16.6815
    412.7945 ± 17.0075
        Change at Day 3 (N= 287, 146)
    9.2509 ± 16.8132
    1 ± 12.5346
    Notes
    [22] - Safety analysis set
    [23] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

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    End point title
    		 Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
    End point description
    QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [24]
    150 [25]
    Units: milliseconds
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (N= 298, 150)
    391.1846 ± 19.1574
    390.9467 ± 18.4339
        Change at Day 1 (N= 290, 148)
    7.0724 ± 11.3219
    1.9122 ± 11.3058
        Day 3: Pre-dose (N= 292, 146)
    397.3767 ± 17.2179
    392.6918 ± 18.8144
        Change at Day 3 (N= 287, 146)
    8.115 ± 13.5805
    1.774 ± 9.3328
    Notes
    [24] - Safety analysis set
    [25] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3

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    End point title
    		 Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
    End point description
    A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [26]
    150 [27]
    Units: Percentage of subjects
    number (not applicable)
        Day1: Pre-dose QTcCalcFridericia>ULN (N= 300, 150)
    0.7
    1.3
        Day1: Post-dose QTcCalcFridericia>ULN (N= 297,148)
    3
    2
        Day1: Post-dose >30 ms from pre-dose (N= 297,148)
    2
    0
        Day1: Post-dose >60 ms from pre-dose (N= 297,148)
    0.3
    0
        Day3: Pre-dose QTcCalcFridericia>ULN (N= 293, 146)
    1.4
    1.4
        Day3: Post-dose QTcCalcFridericia>ULN (N= 291,148)
    9.6
    1.4
        Day3: Post-dose >30 ms from pre-dose (N= 291,148)
    17.9
    3.4
        Day3: Post-dose >60 ms from pre-dose (N= 291,148)
    1.7
    0.7
    Notes
    [26] - Safety analysis set
    [27] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3

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    End point title
    		 Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
    End point description
    A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
    End point type
    Secondary
    End point timeframe
    Baseline (pre-dose), Day 1, Day 3
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    301 [28]
    150 [29]
    Units: Percentage of subjects
    number (not applicable)
        Day1: Pre-dose QTc Calc Bazett > ULN (N= 300, 150)
    7.7
    2.7
        Day1: Post-dose QTc Calc Bazett > ULN (N= 297,148)
    16.2
    4.1
        Day1: Post-dose >30 ms from pre-dose (N= 297,148)
    5.4
    0
        Day1: Post-dose >60 ms from pre-dose (N= 297,148)
    0
    0
        Day3: Pre-dose QTc Calc Bazett > ULN (N= 293, 146)
    3.8
    1.4
        Day3: Post-dose QTc Calc Bazett > ULN (N= 291,148)
    15.5
    3.4
        Day3: Post-dose >30 ms from pre-dose (N= 291,148)
    9.6
    2
        Day3: Post-dose >60 ms from pre-dose (N= 291,148)
    0.7
    0.7
    Notes
    [28] - Safety analysis set
    [29] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Clinical Response at Test-of-Cure (TOC) Visit

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    End point title
    		 Clinical Response at Test-of-Cure (TOC) Visit
    End point description
    Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.
    End point type
    Secondary
    End point timeframe
    28 to 42 days
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    297 [30]
    150 [31]
    Units: Percentage of subjects
    number (not applicable)
        Clinical Cure
    86.2
    95.3
        Clinical Failure
    5.7
    2
        Indeterminate
    8.1
    2.7
    Notes
    [30] - Safety analysis set with subjects evaluable for this outcome
    [31] - Safety analysis set
    No statistical analyses for this end point

    Secondary: Bacteriological Response at Test-of-Cure (TOC) Visit

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    End point title
    		 Bacteriological Response at Test-of-Cure (TOC) Visit
    End point description
    Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate. 'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported.
    End point type
    Secondary
    End point timeframe
    28 to 42 days
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    249 [32]
    136 [33]
    Units: Percentage of subjects
    number (not applicable)
        Presumed Persistence
    6.8
    2.2
        Presumed Eradication
    84.7
    94.9
        Indeterminate
    8.4
    2.9
    Notes
    [32] - Safety analysis set with subjects evaluable for this outcome
    [33] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Secondary: Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)

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    End point title
    		 Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
    End point description
    Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported
    End point type
    Secondary
    End point timeframe
    28 to 42 days
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    297 [34]
    150 [35]
    Units: Percentage of subjects
    number (not applicable)
        Clinical Cure
    86.2
    95.3
        Clinical Failure
    5.7
    2
        Indeterminate
    8.1
    2.7
    Notes
    [34] - Safety analysis set with subjects evaluable for this outcome
    [35] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Secondary: Clinical Response at a ‘During Therapy’ Visit

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    End point title
    		 Clinical Response at a ‘During Therapy’ Visit
    End point description
    Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy. 'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported.
    End point type
    Secondary
    End point timeframe
    Day 3 to Day 5
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    299 [36]
    148 [37]
    Units: Percentage of subjects
    number (not applicable)
        Clinical Improvement
    94.3
    98
        Clinical Failure
    1
    0.7
        Indeterminate
    4.7
    1.4
    Notes
    [36] - Safety analysis set with subjects evaluable for this outcome
    [37] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Secondary: Bacteriological Response at a ‘During Therapy’ Visit

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    End point title
    		 Bacteriological Response at a ‘During Therapy’ Visit
    End point description
    Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported
    End point type
    Secondary
    End point timeframe
    Day 3 to Day 5
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    249 [38]
    134 [39]
    Units: Percentage of subjects
    number (not applicable)
        Presumed Persistence
    1.2
    0.7
        Presumed Eradication
    95.6
    97.8
        Indeterminate
    3.2
    1.5
    Notes
    [38] - Safety analysis set with subjects evaluable for this outcome
    [39] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Secondary: Clinical Response at the End-of-Treatment (EOT) Visit

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    End point title
    		 Clinical Response at the End-of-Treatment (EOT) Visit
    End point description
    Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.
    End point type
    Secondary
    End point timeframe
    Day 5 to Day 14
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    283 [40]
    148 [41]
    Units: Percentage of subjects
    number (not applicable)
        Resolution
    92.2
    98
        Clinical Failure
    4.6
    0.7
        Indeterminate
    3.2
    1.4
    Notes
    [40] - Safety analysis set with subjects evaluable for this outcome
    [41] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Secondary: Bacteriological response at the End of Treatment (EOT) visit

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    End point title
    		 Bacteriological response at the End of Treatment (EOT) visit
    End point description
    Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.
    End point type
    Secondary
    End point timeframe
    Day 5 to Day 14
    End point values
    		 Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
    Number of subjects analysed
    237 [42]
    134 [43]
    Units: Percentage of subjects
    number (not applicable)
        Presumed Persistence
    5.5
    0.7
        Presumed Eradication
    91.1
    97.8
        Indeterminate
    3.4
    1.5
    Notes
    [42] - Safety analysis set with subjects evaluable for this outcome
    [43] - Safety analysis set with subjects evaluable for this outcome
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Comparator Ertapenem
    Reporting group description
    		 Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

    Reporting group title
    Moxifloxacin (Avelox, BAY12-8039)
    Reporting group description
    		 Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.

    Serious adverse events
    		 Comparator Ertapenem Moxifloxacin (Avelox, BAY12-8039)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 150 (4.00%)
    20 / 301 (6.64%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 150 (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
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 150 (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
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 301 (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
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 301 (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
    0 / 150 (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
    General disorders and administration site conditions
    Surgical failure
         subjects affected / exposed
    0 / 150 (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
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 150 (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
    Crohn's disease
         subjects affected / exposed
    0 / 150 (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
    Ileal perforation
         subjects affected / exposed
    0 / 150 (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
    Intestinal obstruction
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 301 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 301 (1.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 150 (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
    Faecalith
         subjects affected / exposed
    0 / 150 (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
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 301 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fasciitis
         subjects affected / exposed
    0 / 150 (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
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    0 / 150 (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
    Peritoneal abscess
         subjects affected / exposed
    0 / 150 (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
    Cellulitis
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 301 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 150 (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
    Abdominal infection
         subjects affected / exposed
    0 / 150 (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
    Abdominal abscess
         subjects affected / exposed
    0 / 150 (0.00%)
    3 / 301 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 150 (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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Comparator Ertapenem Moxifloxacin (Avelox, BAY12-8039)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 150 (42.00%)
    127 / 301 (42.19%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 301 (0.66%)
         occurrences all number
    3
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 301 (1.00%)
         occurrences all number
    2
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 150 (1.33%)
    4 / 301 (1.33%)
         occurrences all number
    2
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 301 (0.66%)
         occurrences all number
    2
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    4 / 150 (2.67%)
    28 / 301 (9.30%)
         occurrences all number
    4
    31
    Lipase increased
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 301 (0.33%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    14 / 150 (9.33%)
    26 / 301 (8.64%)
         occurrences all number
    14
    26
    Wound complication
         subjects affected / exposed
    2 / 150 (1.33%)
    4 / 301 (1.33%)
         occurrences all number
    2
    4
    Postoperative wound complication
         subjects affected / exposed
    2 / 150 (1.33%)
    3 / 301 (1.00%)
         occurrences all number
    2
    4
    Incision site inflammation
         subjects affected / exposed
    3 / 150 (2.00%)
    2 / 301 (0.66%)
         occurrences all number
    3
    2
    Procedural pain
         subjects affected / exposed
    10 / 150 (6.67%)
    16 / 301 (5.32%)
         occurrences all number
    10
    16
    Procedural vomiting
         subjects affected / exposed
    4 / 150 (2.67%)
    0 / 301 (0.00%)
         occurrences all number
    4
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 150 (0.00%)
    8 / 301 (2.66%)
         occurrences all number
    0
    8
    Surgical and medical procedures
    Abdominal cavity drainage
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 301 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 150 (1.33%)
    6 / 301 (1.99%)
         occurrences all number
    2
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 150 (2.67%)
    6 / 301 (1.99%)
         occurrences all number
    4
    6
    Infusion site phlebitis
         subjects affected / exposed
    0 / 150 (0.00%)
    4 / 301 (1.33%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 150 (2.00%)
    8 / 301 (2.66%)
         occurrences all number
    3
    8
    Nausea
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 301 (0.33%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    1 / 150 (0.67%)
    11 / 301 (3.65%)
         occurrences all number
    1
    12
    Vomiting
         subjects affected / exposed
    12 / 150 (8.00%)
    20 / 301 (6.64%)
         occurrences all number
    12
    22
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 150 (1.33%)
    9 / 301 (2.99%)
         occurrences all number
    2
    36
    Joint swelling
         subjects affected / exposed
    2 / 150 (1.33%)
    0 / 301 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    6 / 150 (4.00%)
    13 / 301 (4.32%)
         occurrences all number
    6
    13
    Metabolism and nutrition disorders
    Hyperlipasaemia
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 301 (0.33%)
         occurrences all number
    3
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2010
    1. The sample size was increased from 300 to 450 patients. 2. Stratification of subjects by age was added to the protocol which allows a statistical analysis by age group. 3. A yearly follow-up up to 5 years after EOT was added if a musculoskeletal event has not resolved by the 1-Year Follow-up visit. This extended follow-up should ensure that subjects with unresolved musculoskeletal AEs are followed until resolution of the AE. 4. The list of drugs that might induce QTc prolongation and are therefore not allowed to be co-administered with moxifloxacin was expanded. 5. ECG measurement and interpretation of the results are explained in more detail. 6. Several additional examples of musculoskeletal related adverse events suggested by the FDA were added to the protocol. 7. The consistency of the descriptions of the musculoskeletal clinical and questionnaire assessments at different time points was improved. 8. Text describing how AEs which occur within 7 days of the EOT visit will be assessed and documented was added to the protocol.
    30 Aug 2011
    1. Inclusion and exclusion criteria changed. 2. Post-study therapy description amended. 3. Schedule of procedures amended to clarify procedures during Pre-treatment and During therapy periods of the study. 4. Various editorial changes, minor error correction and clarification were included in amendment 3, as well as revising the format for displaying the literature references.
    07 Aug 2012
    1. Clarifications with regards to ECG recordings as well as use of prior and concomitant medication that may influence QT interval have been added. 2. Clarification on when a premature termination visit is required has been added. 3. The possibility to contact patients by phone in case the do not return for follow-up visits has been introduced. 4. Various editorial changes, minor error correction and clarification were included in amendment 4.
    29 Jan 2013
    1. Clarifications were made regarding dosing for children 3 months to less than 2 years of age.
    29 Jan 2013
    1. Temporal artery was added as a method of body temperature measurement in addition to oral, rectal, and tympanic as this is commonly used in some countries. 2. The reporting period for adverse events (AEs, SAEs, including “Hy’s Law” cases, and deaths) was changed from 7 days following EOT to the TOC visit as agreed to with the European Medicines Agency in the pediatric investigational plan. 3. The definition of significant renal impairment was modified to be consistent with the definition used in IV ertapenem comparator studies. 4. Quinolones have been excluded from allowed pre- and perioperative antibiotic treatment within 12 months prior to study entry. 5. Examination of the Achilles and patellar tendons was added to the skilled musculoskeletal assessment as recommended by an external expert. 6. Specific time points for the measurement of vital signs were added as recommended by the FDA. 7. The wording of the skilled musculoskeletal assessment questionnaire procedure was modified to refer to the correct visit. 8. Documentation of treatment of musculoskeletal AEs was added to be consistent with the CRF.

    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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