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Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection (MOXIPEDIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01069900
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : December 8, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Intraabdominal Infections
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Ertapenem
Drug: Amoxicillin/Clavulanate
Drug: Moxifloxacin placebo
Drug: Ertapenem placebo
Drug: Amoxicillin/Clavulanate placebo
Enrollment 458
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 Details Overall 478 subjects were enrolled, 20 subjects had screening failures hence, 458 subjects were randomized to receive treatment.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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. 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.
Period Title: Overall Study
Started 305 153
Treated 301 150
Completed 287 149
Not Completed 18 4
Reason Not Completed
Technical problems             0             1
Lost to Follow-up             7             1
Withdrawal by Subject             6             1
Protocol Violation             4             1
Insufficient Therapeutic effect             1             0
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem Total
Hide Arm/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. 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. Total of all reporting groups
Overall Number of Baseline Participants 305 153 458
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 153 participants 458 participants
12.05  (3.66) 12.046  (3.495) 12.049  (3.602)
Age, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 305 participants 153 participants 458 participants
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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 153 participants 458 participants
Female
124
  40.7%
53
  34.6%
177
  38.6%
Male
181
  59.3%
100
  65.4%
281
  61.4%
1.Primary Outcome
Title Number of Subjects With Adverse Events
Hide 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Unit of Measure: Subjects
Any AE 175 82
Any SAE 20 6
2.Primary Outcome
Title Number of Subjects With Clinical Cardiac Adverse Events
Hide Description [Not Specified]
Time Frame Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Unit of Measure: Subjects
Any AE 38 7
Any SAE 0 0
3.Primary Outcome
Title Number of Subjects With Musculoskeletal Adverse Events
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Unit of Measure: Subjects
Any AE 13 5
Any SAE 1 0
4.Secondary Outcome
Title Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
Hide 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Forearm fracture
0.3
(0.01 to 1.84)
0
(0 to 2.43)
Joint injury
0
(0 to 1.22)
0.7
(0.02 to 3.66)
Ligament sprain
0.3
(0.01 to 1.84)
0.7
(0.02 to 3.66)
Muscle strain
0
(0 to 1.22)
0.7
(0.02 to 3.66)
Arthralgia
3
(1.38 to 5.6)
1.3
(0.16 to 4.73)
Joint swelling
0
(0 to 1.22)
0.7
(0.02 to 3.66)
Musculoskeletal pain
1
(0.21 to 2.88)
0
(0 to 2.43)
Myalgia
0.3
(0.01 to 1.84)
0
(0 to 2.43)
5.Secondary Outcome
Title Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Hide Description "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
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)
6.Secondary Outcome
Title PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
7.Secondary Outcome
Title RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
8.Secondary Outcome
Title QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
9.Secondary Outcome
Title QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
10.Secondary Outcome
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
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
11.Secondary Outcome
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
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Mean (Standard Deviation)
Unit of Measure: milliseconds
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)
12.Secondary Outcome
Title Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Unit of Measure: Percentage of subjects
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
13.Secondary Outcome
Title Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
Hide 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.
Time Frame Baseline (Pre-dose), Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 301 150
Measure Type: Number
Unit of Measure: Percentage of subjects
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
14.Secondary Outcome
Title Clinical Response at Test-of-Cure (TOC) Visit
Hide 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.
Time Frame 28 to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set with subjects evaluable for this outcome
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
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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.
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.
Overall Number of Participants Analyzed 297 150
Measure Type: Number
Unit of Measure: Percentage of subjects
Clinical Cure 86.2 95.3
Clinical Failure 5.7 2
Indeterminate 8.1 2.7
15.Secondary Outcome
Title Bacteriological Response at Test-of-Cure (TOC) Visit
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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.

Time Frame 28 to 42 days
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Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
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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.
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.
Overall Number of Participants Analyzed 249 136
Measure Type: Number
Unit of Measure: Percentage of subjects
Presumed Persistence 6.8 2.2
Presumed Eradication 84.7 94.9
Indeterminate 8.4 2.9
16.Secondary Outcome
Title Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
Hide 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
Time Frame 28 to 42 days
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Safety analysis set with subjects evaluable for this outcome
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
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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.
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.
Overall Number of Participants Analyzed 297 150
Measure Type: Number
Unit of Measure: Percentage of subjects
Clinical Cure 86.2 95.3
Clinical Failure 5.7 2
Indeterminate 8.1 2.7
17.Secondary Outcome
Title Clinical Response at a 'During Therapy' Visit
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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.

Time Frame Day 3 to Day 5
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Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
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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.
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.
Overall Number of Participants Analyzed 299 148
Measure Type: Number
Unit of Measure: Percentage of subjects
Clinical Improvement 94.3 98
Clinical Failure 1 0.7
Indeterminate 4.7 1.4
18.Secondary Outcome
Title Bacteriological Response at a 'During Therapy' Visit
Hide 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, pretreatment 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
Time Frame Day 3 to Day 5
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Safety analysis set with subjects evaluable for this outcome
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
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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.
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.
Overall Number of Participants Analyzed 249 134
Measure Type: Number
Unit of Measure: Percentage of subjects
Presumed Persistence 1.2 0.7
Presumed Eradication 95.6 97.8
Indeterminate 3.2 1.5
19.Secondary Outcome
Title Clinical Response at the End-of-Treatment (EOT) Visit
Hide 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.
Time Frame Day 5 to Day 14
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Safety analysis set with subjects evaluable for this outcome
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 283 148
Measure Type: Number
Unit of Measure: Percentage of subjects
Resolution 92.2 98
Clinical Failure 4.6 0.7
Indeterminate 3.2 1.4
20.Secondary Outcome
Title Bacteriological Response at the End of Treatment (EOT) Visit
Hide 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, pretreatment 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.
Time Frame Day 5 to Day 14
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Safety analysis set with subjects evaluable for this outcome
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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.
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.
Overall Number of Participants Analyzed 237 134
Measure Type: Number
Unit of Measure: Percentage of subjects
Presumed Persistence 5.5 0.7
Presumed Eradication 91.1 97.8
Indeterminate 3.4 1.5
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Hide Arm/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. 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.
All-Cause Mortality
Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
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Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/301 (6.64%)      6/150 (4.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Congenital, familial and genetic disorders     
Phimosis * 1  0/301 (0.00%)  0 1/150 (0.67%)  1
Gastrointestinal disorders     
Constipation * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Crohn's disease * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Ileal perforation * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Intestinal obstruction * 1  2/301 (0.66%)  2 0/150 (0.00%)  0
Mechanical ileus * 1  3/301 (1.00%)  3 2/150 (1.33%)  2
Enterocutaneous fistula * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Faecalith * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Functional gastrointestinal disorder * 1  2/301 (0.66%)  2 0/150 (0.00%)  0
General disorders     
Surgical failure * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Infections and infestations     
Abdominal wall abscess * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Cellulitis * 1  0/301 (0.00%)  0 1/150 (0.67%)  1
Peritoneal abscess * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Wound infection * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Abdominal infection * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Abdominal abscess * 1  3/301 (1.00%)  3 0/150 (0.00%)  0
Injury, poisoning and procedural complications     
Facial bones fracture * 1  0/301 (0.00%)  0 1/150 (0.67%)  1
Forearm fracture * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Abdominal wound dehiscence * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fasciitis * 1  1/301 (0.33%)  1 0/150 (0.00%)  0
Nervous system disorders     
Generalised tonic-clonic seizure * 1  0/301 (0.00%)  0 1/150 (0.67%)  1
Idiopathic generalised epilepsy * 1  0/301 (0.00%)  0 1/150 (0.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Moxifloxacin (Avelox, BAY12-8039) Comparator Ertapenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   127/301 (42.19%)      63/150 (42.00%)    
Gastrointestinal disorders     
Abdominal pain * 1  8/301 (2.66%)  8 3/150 (2.00%)  3
Diarrhoea * 1  11/301 (3.65%)  12 1/150 (0.67%)  1
Nausea * 1  1/301 (0.33%)  1 2/150 (1.33%)  2
Vomiting * 1  20/301 (6.64%)  22 12/150 (8.00%)  12
General disorders     
Pyrexia * 1  6/301 (1.99%)  6 4/150 (2.67%)  4
Infusion site phlebitis * 1  4/301 (1.33%)  6 0/150 (0.00%)  0
Infections and infestations     
Wound infection * 1  13/301 (4.32%)  13 6/150 (4.00%)  6
Injury, poisoning and procedural complications     
Wound complication * 1  4/301 (1.33%)  4 2/150 (1.33%)  2
Incision site pain * 1  26/301 (8.64%)  26 14/150 (9.33%)  14
Postoperative wound complication * 1  3/301 (1.00%)  4 2/150 (1.33%)  2
Procedural pain * 1  16/301 (5.32%)  16 10/150 (6.67%)  10
Incision site inflammation * 1  2/301 (0.66%)  2 3/150 (2.00%)  3
Procedural vomiting * 1  0/301 (0.00%)  0 4/150 (2.67%)  4
Investigations     
Alanine aminotransferase increased * 1  3/301 (1.00%)  3 2/150 (1.33%)  2
Aspartate aminotransferase increased * 1  2/301 (0.66%)  2 3/150 (2.00%)  3
Blood creatine phosphokinase increased * 1  4/301 (1.33%)  4 2/150 (1.33%)  2
Electrocardiogram QT prolonged * 1  28/301 (9.30%)  31 4/150 (2.67%)  4
Gamma-glutamyltransferase increased * 1  2/301 (0.66%)  2 2/150 (1.33%)  2
Lipase increased * 1  1/301 (0.33%)  1 2/150 (1.33%)  2
Metabolism and nutrition disorders     
Hyperlipasaemia * 1  1/301 (0.33%)  1 2/150 (1.33%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  9/301 (2.99%)  36 2/150 (1.33%)  2
Joint swelling * 1  0/301 (0.00%)  0 2/150 (1.33%)  2
Nervous system disorders     
Headache * 1  6/301 (1.99%)  6 2/150 (1.33%)  2
Surgical and medical procedures     
Abdominal cavity drainage * 1  0/301 (0.00%)  0 2/150 (1.33%)  2
Vascular disorders     
Phlebitis * 1  8/301 (2.66%)  8 0/150 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreed point of publication is 12/18 months after database lock at the earliest.

  • Bayer will have up to 30/45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable).
  • No publication of single center data should be done prior of publication if multi-center data.
Results Point of Contact
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Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01069900    
Other Study ID Numbers: 11643
1962 (Avelox pediatrics) ( Other Identifier: Company internal )
2009-015578-37 ( EudraCT Number )
First Submitted: February 15, 2010
First Posted: February 17, 2010
Results First Submitted: November 4, 2015
Results First Posted: December 8, 2015
Last Update Posted: March 20, 2018