Trial · NCT00492726
Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem
NCT00492726, Phase 3, Completed, Bayer; results first posted 2010-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem. Trials, record NCT00492726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00492726
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem
- NCT number
- NCT00492726
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 804 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Infection
- Interventions
- Moxifloxacin (Avelox, BAY12-8039), Ertapenem intravenous
- First posted
- 2007-06-27
- Last updated
- 2014-11-07
- Other registries' IDs
- eudract:2006-000874-56
- Results first posted
- 2010-03-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | 21 to 28 days after completion of study drug therapy | 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. |
| Secondary | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | During treatment at day 5 +/- 1 day | 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. |
| Secondary | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | During treatment at day 5 +/- 1 day | Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'. |
| Secondary | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | after 5 - 14 days of therapy | 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. |
| Secondary | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | After 5 - 14 days of therapy | Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'. |
| Secondary | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | 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. |
| Secondary | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | 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. |
| Secondary | Number of Subjects Who Died Due to Intra-abdominal Infections | 21 - 28 days after end of treatment at TOC Visit | Number of subjects who had died due to intra abdominal infections by the time of TOC visit. |
| Secondary | Duration of Hospitalization | From the first admission date to the discharge date (from 4 to 71 days after start of study medication) | Duration of hospitalization in the per protocol population. |
| Secondary | Duration of Hospitalization Postoperatively | Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication) | Duration of hospitalization after the first surgery until discharge in the per protocol population. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | 21 to 28 days after completion of study drug therapy | 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. | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | During treatment at day 5 +/- 1 day | Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome. | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | During treatment at day 5 +/- 1 day | Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | after 5 - 14 days of therapy | Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome. | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | After 5 - 14 days of therapy | 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). | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). | participants | NUMBER |
| SECONDARY | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). | participants | NUMBER |
| SECONDARY | Number of Subjects Who Died Due to Intra-abdominal Infections | 21 - 28 days after end of treatment at TOC Visit | Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome. | participants | NUMBER |
| SECONDARY | Duration of Hospitalization | From the first admission date to the discharge date (from 4 to 71 days after start of study medication) | Numbers refer to patients in the per protocol population with known end of hospitalization date. | days | MEAN |
| SECONDARY | Duration of Hospitalization Postoperatively | Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication) | Numbers refer to patients in the per protocol population with known end of hospitalization date. | days | MEAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Moxifloxacin (Avelox, BAY12-8039) | Clinical Cure | 315 | participants | |
| Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Ertapenem | Clinical Cure | 324 | participants | |
| Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Moxifloxacin (Avelox, BAY12-8039) | Clinical Failure | 37 | participants | |
| Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Ertapenem | Clinical Failure | 23 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Moxifloxacin (Avelox, BAY12-8039) | Clinical Improvement | 210 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Ertapenem | Clinical Improvement | 194 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Moxifloxacin (Avelox, BAY12-8039) | Clinical Failure | 0 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Ertapenem | Clinical Failure | 2 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Moxifloxacin (Avelox, BAY12-8039) | Missing | 142 | participants | |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Ertapenem | Missing | 151 | participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxifloxacin (Avelox, BAY12-8039) | 410 | |
| Overall Study | STARTED | Ertapenem | 394 | |
| Overall Study | End of Treatment (EOT, Day 5 to 14) | Moxifloxacin (Avelox, BAY12-8039) | 387 | |
| Overall Study | End of Treatment (EOT, Day 5 to 14) | Ertapenem | 377 | |
| Overall Study | End of Study | Moxifloxacin (Avelox, BAY12-8039) | 360 | |
| Overall Study | End of Study | Ertapenem | 358 | |
| Overall Study | COMPLETED | Moxifloxacin (Avelox, BAY12-8039) | 360 | |
| Overall Study | COMPLETED | Ertapenem | 358 | |
| Overall Study | NOT COMPLETED | Moxifloxacin (Avelox, BAY12-8039) | 50 | |
| Overall Study | NOT COMPLETED | Ertapenem | 36 |
Source ClinicalTrials.gov
Adverse events206
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Moxifloxacin (Avelox, BAY12-8039) | 23 | 408 | 23 |
| other | Diarrhoea | Gastrointestinal disorders | Ertapenem | 18 | 390 | 18 |
| other | Nausea | Gastrointestinal disorders | Moxifloxacin (Avelox, BAY12-8039) | 30 | 408 | 33 |
| other | Nausea | Gastrointestinal disorders | Ertapenem | 17 | 390 | 18 |
| other | Wound infection | Infections and infestations | Moxifloxacin (Avelox, BAY12-8039) | 37 | 408 | 37 |
| other | Wound infection | Infections and infestations | Ertapenem | 28 | 390 | 28 |
| other | Lipase increased | Investigations | Moxifloxacin (Avelox, BAY12-8039) | 25 | 408 | 25 |
| other | Lipase increased | Investigations | Ertapenem | 24 | 390 | 24 |
| serious | Acute mycardial infarction | Cardiac disorders | Moxifloxacin (Avelox, BAY12-8039) | 2 | 408 | 2 |
| serious | Acute mycardial infarction | Cardiac disorders | Ertapenem | 0 | 390 | 0 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxifloxacin (Avelox, BAY12-8039) | ||
| Total, all-cause mortality | Ertapenem | ||
| Total, other adverse events | Moxifloxacin (Avelox, BAY12-8039) | 115 | 408 |
| Total, other adverse events | Ertapenem | 87 | 390 |
| Total, serious adverse events | Moxifloxacin (Avelox, BAY12-8039) | 60 | 408 |
| Total, serious adverse events | Ertapenem | 48 | 390 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23153963 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Moxifloxacin (Avelox, BAY12-8039) vs Ertapenem: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00492726
GET https://conductscience.org/api/trials/v1/NCT00492726/results?page=2