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Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

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: NCT00492726
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : March 3, 2010
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Infection
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Ertapenem intravenous
Enrollment 804
Recruitment Details Subjects were enrolled from 02 July 2006 to 31 December 2008 at 52 centers in 14 countries: Argentina (9), Belgium (3), Bulgaria (4), Estonia (3), France (2 ), Germany (5), Greece (1), Israel (2), Latvia (6), Lithuania (4), Romania (5), Russia (3), South Africa (3), and Spain (2).
Pre-assignment Details 830 subjects screened, 804 randomized. 6 not treated. Safety/Intent to treat population = 798 subjects with at least 1 dose taken and 1 observation after intake (Moxifloxacin 408; Ertapenem 390). Per protocol population = 699 subjects with no major protocol deviations that would have influenced the primary outcome (Moxifloxacin 352; Ertapenem 347).
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Period Title: Overall Study
Started 410 394
End of Treatment (EOT, Day 5 to 14) 387 377
End of Study 360 358
Completed 360 358
Not Completed 50 36
Reason Not Completed
Adverse Event             10             6
Death             7             2
Lack of Efficacy             0             2
Lost to Follow-up             27             19
Physician Decision             0             1
Withdrawal by Subject             6             3
Non compliant with study medication             0             3
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem Total
Hide Arm/Group Description Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 410 394 804
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 410 participants 394 participants 804 participants
48.1  (18.3) 47.0  (18.2) 47.4  (18.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 410 participants 394 participants 804 participants
Female
156
  38.0%
131
  33.2%
287
  35.7%
Male
254
  62.0%
263
  66.8%
517
  64.3%
1.Primary Outcome
Title Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
Hide Description Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time Frame 21 to 28 days after completion of study drug therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 352 347
Measure Type: Number
Unit of Measure: participants
Clinical Cure 315 324
Clinical Failure 37 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.
Method of Estimation Estimation Parameter Difference of cure rates (in percent)
Estimated Value -3.8
Confidence Interval 95%
-7.9 to 0.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
2.Secondary Outcome
Title Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Hide Description Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
Time Frame During treatment at day 5 +/- 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 352 347
Measure Type: Number
Unit of Measure: participants
Clinical Improvement 210 194
Clinical Failure 0 2
Missing 142 151
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference in improvement rates (in %)
Estimated Value 1.1
Confidence Interval 95%
-0.4 to 2.7
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
3.Secondary Outcome
Title Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Hide Description Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.
Time Frame During treatment at day 5 +/- 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 297 276
Measure Type: Number
Unit of Measure: participants
Eradication 5 5
Presumed Eradication 170 149
Persistence 16 7
Presumed Persistence 0 2
Superinfections 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference in bact. success rates (in %)
Estimated Value -3.9
Confidence Interval 95%
-8.8 to 1.0
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.
4.Secondary Outcome
Title Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Hide Description Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
Time Frame after 5 - 14 days of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 352 347
Measure Type: Number
Unit of Measure: participants
Clinical Cure 328 330
Clinical Failure 23 17
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of cure rates (in percent)
Estimated Value -1.5
Confidence Interval 95%
-5.0 to 1.9
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
5.Secondary Outcome
Title Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Hide Description Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.
Time Frame After 5 - 14 days of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 297 276
Measure Type: Number
Unit of Measure: participants
Eradication 5 7
Presumed Eradication 257 247
Persistence 20 9
Presumed Persistence 13 11
Superinfections 1 2
Indeterminate/missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference in bact. success rates (in %)
Estimated Value -3.9
Confidence Interval 95%
-8.8 to 1.0
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.
6.Secondary Outcome
Title Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Hide Description Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’ – additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.
Time Frame 21 - 28 days after end of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 297 276
Measure Type: Number
Unit of Measure: participants
Eradication 0 0
Presumed Eradication 257 249
Persistence 20 9
Presumed Persistence 20 18
Superinfections 0 0
Reinfections 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference in bact. success rates (in %)
Estimated Value -3.8
Confidence Interval 95%
-9.0 to 1.5
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.
7.Secondary Outcome
Title Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
Hide Description Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time Frame 21 - 28 days after end of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 297 276
Measure Type: Number
Unit of Measure: participants
Clinical Cure 265 254
Clinical Failure 32 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Ertapenem
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of cure rates (in percent)
Estimated Value -2.9
Confidence Interval 95%
-7.6 to 1.9
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
8.Secondary Outcome
Title Number of Subjects Who Died Due to Intra-abdominal Infections
Hide Description Number of subjects who had died due to intra abdominal infections by the time of TOC visit.
Time Frame 21 - 28 days after end of treatment at TOC Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 352 347
Measure Type: Number
Unit of Measure: participants
Yes 3 1
No 349 346
9.Secondary Outcome
Title Duration of Hospitalization
Hide Description Duration of hospitalization in the per protocol population.
Time Frame From the first admission date to the discharge date (from 4 to 71 days after start of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers refer to patients in the per protocol population with known end of hospitalization date.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 346 343
Mean (Standard Deviation)
Unit of Measure: days
11.7  (7.3) 11.2  (7.8)
10.Secondary Outcome
Title Duration of Hospitalization Postoperatively
Hide Description Duration of hospitalization after the first surgery until discharge in the per protocol population.
Time Frame Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers refer to patients in the per protocol population with known end of hospitalization date.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description:
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
Overall Number of Participants Analyzed 346 343
Mean (Standard Deviation)
Unit of Measure: days
11.1  (7.1) 10.7  (7.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Hide Arm/Group Description Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
All-Cause Mortality
Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/408 (14.71%)      48/390 (12.31%)    
Cardiac disorders     
Acute mycardial infarction * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Atrial fibrillation * 1  0/408 (0.00%)  0 2/390 (0.51%)  2
Atrial flutter * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Cardiac arrest * 1  7/408 (1.72%)  7 2/390 (0.51%)  3
Cardiac failure acute * 1  1/408 (0.25%)  1 1/390 (0.26%)  1
Cardio-respiratory arrest * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Cardiogenic shock * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Ventricular tachycardia * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Tachyarrhythmia * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Cardiopulmonary failure * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Gastrointestinal disorders     
Colonic fistula * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Duodenal ulcer perforation * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Duodenitis * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Gastric haemorrhage * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Gastrointestinal fistula * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Gastrointestinal haemorrhage * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Ileus * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Inguinal hernia * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Intestinal fistula * 1  1/408 (0.25%)  1 3/390 (0.77%)  4
Intestinal obstruction * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Large intestine perforation * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Nausea * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Peritonitis * 1  3/408 (0.74%)  3 2/390 (0.51%)  2
Small intestinal obstruction * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Upper gastrointestinal haemorrhage * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Vomiting * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Mechanical ileus * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Jejunal fistula * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
General disorders     
Impaired healing * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Multi-organ failure * 1  4/408 (0.98%)  4 2/390 (0.51%)  2
Unevaluable event * 1  4/408 (0.98%)  4 2/390 (0.51%)  2
Hepatobiliary disorders     
Acute hepatic failure * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Portal vein thrombosis * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Infections and infestations     
Abdominal wall abscess * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Abscess intestinal * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Bronchopneumonia * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Clostridium difficile colitis * 1  1/408 (0.25%)  1 1/390 (0.26%)  1
Disseminated tuberculosis * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Empyema * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Gastroenteritis * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Peritoneal abscess * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Pneumonia * 1  1/408 (0.25%)  1 4/390 (1.03%)  4
Postoperative wound infection * 1  2/408 (0.49%)  2 2/390 (0.51%)  2
Retroperitoneal abscess * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Sepsis * 1  3/408 (0.74%)  3 1/390 (0.26%)  1
Septic shock * 1  3/408 (0.74%)  3 0/390 (0.00%)  0
Wound infection * 1  10/408 (2.45%)  10 1/390 (0.26%)  1
Rectal abscess * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Appendiceal abscess * 1  0/408 (0.00%)  0 2/390 (0.51%)  2
Haematoma infection * 1  1/408 (0.25%)  1 1/390 (0.26%)  1
Subdiaphragmatic abscess * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Abdominal infection * 1  1/408 (0.25%)  1 1/390 (0.26%)  1
Wound sepsis * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Wound abscess * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Abdominal abscess * 1  2/408 (0.49%)  2 1/390 (0.26%)  1
Soft tissue infection * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Post procedural sepsis * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Injury, poisoning and procedural complications     
Failure to anastomose * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Hand fracture * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Wound dehiscence * 1  2/408 (0.49%)  2 1/390 (0.26%)  1
Postoperative ileus * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Wound evisceration * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Postoperative respiratory distress * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Post procedural bile leak * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Procedural complication * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Anastomotic complication * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Gastrointestinal disorder postoperative * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Intestinal anastomosis complication * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Investigations     
Chest X-ray abnormal * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Hepatic enzyme increased * 1  2/408 (0.49%)  2 0/390 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Hypoglycaemia * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Colon cancer * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Hairy cell leukaemia * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Coma * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Convulsion * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Hemiplegia * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Subarachnoid haemorrhage * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Ischaemic stroke * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Psychiatric disorders     
Agitation * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Renal and urinary disorders     
Renal failure * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Renal failure acute * 1  4/408 (0.98%)  4 1/390 (0.26%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  3/408 (0.74%)  3 1/390 (0.26%)  1
Acute respiratory failure * 1  2/408 (0.49%)  2 1/390 (0.26%)  1
Apnoea * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Aspiration * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Pleural effusion * 1  3/408 (0.74%)  3 0/390 (0.00%)  0
Pleurisy * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Pulmonary embolism * 1  2/408 (0.49%)  2 2/390 (0.51%)  2
Respiratory arrest * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Respiratory distress * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Respiratory failure * 1  3/408 (0.74%)  3 1/390 (0.26%)  1
Hydropneumothorax * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Vascular disorders     
Hypotension * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Shock * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
Deep vein thrombosis * 1  1/408 (0.25%)  1 0/390 (0.00%)  0
Cardiovascular insufficiency * 1  0/408 (0.00%)  0 1/390 (0.26%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin (Avelox, BAY12-8039) Ertapenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/408 (28.19%)      87/390 (22.31%)    
Gastrointestinal disorders     
Diarrhoea * 1  23/408 (5.64%)  23 18/390 (4.62%)  18
Nausea * 1  30/408 (7.35%)  33 17/390 (4.36%)  18
Infections and infestations     
Wound infection * 1  37/408 (9.07%)  37 28/390 (7.18%)  28
Investigations     
Lipase increased * 1  25/408 (6.13%)  25 24/390 (6.15%)  24
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492726     History of Changes
Other Study ID Numbers: 11976
2006-000874-56 ( EudraCT Number )
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: February 11, 2010
Results First Posted: March 3, 2010
Last Update Posted: November 7, 2014