Phase 2
N=204
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Complicated Intra-abdominal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00752219 ↗Enrolled (actual)
204
Serious AEs
9.9%
Results posted
Jul 2018
Primary outcome: Primary: Number of Participants With Clinical Response at the Test of Cure (TOC) Visit — 62; 71 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ceftazidime/NXL104 + metronidazole (Drug); meropenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response at the Test of Cure (TOC) Visit |
62; 71 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
65; 59; 9; 11 | — |
| SECONDARY Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy |
66; 74 | — |
| SECONDARY Number of Participants With Clinical Response at the Late Follow-up Visit |
62; 71 | — |
| SECONDARY Number of Participants With Microbiological Response at the Test of Cure Visit |
62; 71 | — |
| SECONDARY Number of Participants With Microbiological Response at the End of IV Therapy |
66; 74 | — |
| SECONDARY Number of Participants With Microbiological Response at the Late Follow-up Visit |
62; 71 | — |
| SECONDARY Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit |
80; 85 | — |
| SECONDARY Number of Participants With Clinical Response in CE Participants at the End of IV Therapy |
84; 87 | — |
| SECONDARY Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit |
79; 84 | — |
Summary
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.
Eligibility Criteria
Inclusion Criteria
- complicated intra-abdominal infections
Exclusion Criteria
- infections limited to hollow viscus
- ischemic bowel disease without perforation
- acute suppurative cholangitis
- acute necrotizing pancreatitis
- pts to undergo stated abdominal repair, open abdomen technique or marsupialization
- Apache II >25
Data sourced from ClinicalTrials.gov (NCT00752219). 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.