Trial Outcomes & Findings for Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem (NCT NCT00492726)
NCT ID: NCT00492726
Last Updated: 2014-11-07
Results Overview
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.
COMPLETED
PHASE3
804 participants
21 to 28 days after completion of study drug therapy
2014-11-07
Participant Flow
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).
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).
Participant milestones
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
410
|
394
|
|
Overall Study
End of Treatment (EOT, Day 5 to 14)
|
387
|
377
|
|
Overall Study
End of Study
|
360
|
358
|
|
Overall Study
COMPLETED
|
360
|
358
|
|
Overall Study
NOT COMPLETED
|
50
|
36
|
Reasons for withdrawal
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Death
|
7
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
27
|
19
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Non compliant with study medication
|
0
|
3
|
Baseline Characteristics
Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem
Baseline characteristics by cohort
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=410 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=394 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
Total
n=804 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 18.3 • n=99 Participants
|
47.0 years
STANDARD_DEVIATION 18.2 • n=107 Participants
|
47.4 years
STANDARD_DEVIATION 18.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
156 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=99 Participants
|
263 Participants
n=107 Participants
|
517 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 21 to 28 days after completion of study drug therapyPopulation: 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.
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=352 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=347 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
Clinical Cure
|
315 participants
|
324 participants
|
|
Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
Clinical Failure
|
37 participants
|
23 participants
|
SECONDARY outcome
Timeframe: During treatment at day 5 +/- 1 dayPopulation: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=352 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=347 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Clinical Improvement
|
210 participants
|
194 participants
|
|
Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Clinical Failure
|
0 participants
|
2 participants
|
|
Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Missing
|
142 participants
|
151 participants
|
SECONDARY outcome
Timeframe: During treatment at day 5 +/- 1 dayPopulation: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=297 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=276 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Eradication
|
5 participants
|
5 participants
|
|
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Presumed Eradication
|
170 participants
|
149 participants
|
|
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Persistence
|
16 participants
|
7 participants
|
|
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Presumed Persistence
|
0 participants
|
2 participants
|
|
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Superinfections
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: after 5 - 14 days of therapyPopulation: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=352 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=347 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Clinical Cure
|
328 participants
|
330 participants
|
|
Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Clinical Failure
|
23 participants
|
17 participants
|
|
Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Missing
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: After 5 - 14 days of therapyPopulation: 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).
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=297 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=276 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Eradication
|
5 participants
|
7 participants
|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Presumed Eradication
|
257 participants
|
247 participants
|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Persistence
|
20 participants
|
9 participants
|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Presumed Persistence
|
13 participants
|
11 participants
|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Superinfections
|
1 participants
|
2 participants
|
|
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Indeterminate/missing
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 21 - 28 days after end of therapyPopulation: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=297 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=276 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Eradication
|
0 participants
|
0 participants
|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Presumed Eradication
|
257 participants
|
249 participants
|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Persistence
|
20 participants
|
9 participants
|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Presumed Persistence
|
20 participants
|
18 participants
|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Superinfections
|
0 participants
|
0 participants
|
|
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Reinfections
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 21 - 28 days after end of therapyPopulation: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=297 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=276 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
Clinical Cure
|
265 participants
|
254 participants
|
|
Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
Clinical Failure
|
32 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 21 - 28 days after end of treatment at TOC VisitPopulation: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
Number of subjects who had died due to intra abdominal infections by the time of TOC visit.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=352 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=347 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Number of Subjects Who Died Due to Intra-abdominal Infections
Yes
|
3 participants
|
1 participants
|
|
Number of Subjects Who Died Due to Intra-abdominal Infections
No
|
349 participants
|
346 participants
|
SECONDARY outcome
Timeframe: From the first admission date to the discharge date (from 4 to 71 days after start of study medication)Population: Numbers refer to patients in the per protocol population with known end of hospitalization date.
Duration of hospitalization in the per protocol population.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=346 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=343 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Duration of Hospitalization
|
11.7 days
Standard Deviation 7.3
|
11.2 days
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)Population: Numbers refer to patients in the per protocol population with known end of hospitalization date.
Duration of hospitalization after the first surgery until discharge in the per protocol population.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=346 Participants
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=343 Participants
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Duration of Hospitalization Postoperatively
|
11.1 days
Standard Deviation 7.1
|
10.7 days
Standard Deviation 7.2
|
Adverse Events
Moxifloxacin (Avelox, BAY12-8039)
Ertapenem
Serious adverse events
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=408 participants at risk
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=390 participants at risk
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Cardiac disorders
Acute mycardial infarction
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/408
|
0.51%
2/390 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
7/408 • Number of events 7
|
0.51%
2/390 • Number of events 3
|
|
Cardiac disorders
Cardiac failure acute
|
0.25%
1/408 • Number of events 1
|
0.26%
1/390 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Colonic fistula
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.25%
1/408 • Number of events 1
|
0.77%
3/390 • Number of events 4
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Nausea
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Peritonitis
|
0.74%
3/408 • Number of events 3
|
0.51%
2/390 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Gastrointestinal disorders
Jejunal fistula
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
General disorders
Impaired healing
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
General disorders
Multi-organ failure
|
0.98%
4/408 • Number of events 4
|
0.51%
2/390 • Number of events 2
|
|
General disorders
Unevaluable event
|
0.98%
4/408 • Number of events 4
|
0.51%
2/390 • Number of events 2
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Abdominal wall abscess
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.25%
1/408 • Number of events 1
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Disseminated tuberculosis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Empyema
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Peritoneal abscess
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Pneumonia
|
0.25%
1/408 • Number of events 1
|
1.0%
4/390 • Number of events 4
|
|
Infections and infestations
Postoperative wound infection
|
0.49%
2/408 • Number of events 2
|
0.51%
2/390 • Number of events 2
|
|
Infections and infestations
Retroperitoneal abscess
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Infections and infestations
Sepsis
|
0.74%
3/408 • Number of events 3
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.74%
3/408 • Number of events 3
|
0.00%
0/390
|
|
Infections and infestations
Wound infection
|
2.5%
10/408 • Number of events 10
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/408
|
0.51%
2/390 • Number of events 2
|
|
Infections and infestations
Haematoma infection
|
0.25%
1/408 • Number of events 1
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.25%
1/408 • Number of events 1
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Wound abscess
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Abdominal abscess
|
0.49%
2/408 • Number of events 2
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Infections and infestations
Post procedural sepsis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.49%
2/408 • Number of events 2
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.49%
2/408 • Number of events 2
|
0.00%
0/390
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Nervous system disorders
Coma
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Nervous system disorders
Convulsion
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Nervous system disorders
Hemiplegia
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Psychiatric disorders
Agitation
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.98%
4/408 • Number of events 4
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.74%
3/408 • Number of events 3
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.49%
2/408 • Number of events 2
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.74%
3/408 • Number of events 3
|
0.00%
0/390
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
2/408 • Number of events 2
|
0.51%
2/390 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.74%
3/408 • Number of events 3
|
0.26%
1/390 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Vascular disorders
Shock
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/408 • Number of events 1
|
0.00%
0/390
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.00%
0/408
|
0.26%
1/390 • Number of events 1
|
Other adverse events
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=408 participants at risk
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
|
Ertapenem
n=390 participants at risk
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
23/408 • Number of events 23
|
4.6%
18/390 • Number of events 18
|
|
Gastrointestinal disorders
Nausea
|
7.4%
30/408 • Number of events 33
|
4.4%
17/390 • Number of events 18
|
|
Infections and infestations
Wound infection
|
9.1%
37/408 • Number of events 37
|
7.2%
28/390 • Number of events 28
|
|
Investigations
Lipase increased
|
6.1%
25/408 • Number of events 25
|
6.2%
24/390 • Number of events 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER