Phase 3
N=804
Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem
Infection
Bottom Line
View on ClinicalTrials.gov: NCT00492726 ↗Enrolled (actual)
804
Serious AEs
13.5%
Results posted
Mar 2010
Primary outcome: Primary: Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population — 315; 324; 37; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxifloxacin (Avelox, BAY12-8039) (Drug); Ertapenem intravenous (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population |
315; 324; 37; 23 | — |
| SECONDARY Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population |
210; 194; 0; 2; 142; 151 | — |
| SECONDARY Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) |
5; 5; 170; 149; 16; 7 | — |
| SECONDARY Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population |
328; 330; 23; 17; 1; 0 | — |
| SECONDARY Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) |
5; 7; 257; 247; 20; 9 | — |
| SECONDARY Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) |
0; 0; 257; 249; 20; 9 | — |
| SECONDARY Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) |
265; 254; 32; 22 | — |
| SECONDARY Number of Subjects Who Died Due to Intra-abdominal Infections |
3; 1; 349; 346 | — |
| SECONDARY Duration of Hospitalization |
11.7; 11.2 | — |
| SECONDARY Duration of Hospitalization Postoperatively |
11.1; 10.7 | — |
Summary
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
Eligibility Criteria
Inclusion Criteria
- Hospitalized men or women >/=18 years of age
- Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days
- Ability to provide documented and signed written informed consent
- Confirmed or suspected intra abdominal infection defined as follows:
- For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following:
- Gross peritoneal inflammation with purulent exudates (i.e. peritonitis)
- Intra abdominal abscess
- Macroscopic intestinal perforation with localized or diffuse peritonitis
- Subjects enrolled on the basis of a suspected intra abdominal infection must have:
- Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms:
- Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain), lasting for at least 24 hours
- Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
- At least two of the following SIRS criteria:
- Temperature > 38.0°C rectal or tympanic membrane, or temperature 90/min
- Respiratory rate > 20/min
- WBC >12, 000 cells/mm3 or 15 mg/day of systemic prednisone or equivalent)
- Subjects known to have AIDS (CD4 count /= 45 kg/m2
- Previous enrollment in this study
- Participation in any clinical investigational drug study within the previous 4 weeks
Data sourced from ClinicalTrials.gov (NCT00492726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.