Phase 3
N=1,058
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Complicated Intra-Abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT01499290 ↗Enrolled (actual)
1,058
Serious AEs
3.0%
Results posted
Mar 2016
Primary outcome: Primary: Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). — 337; 349; 37; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CAZ-AVI (Drug); Metronidazole (Drug); Meropenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA). |
337; 349; 37; 30; 39; 31 | — |
| PRIMARY Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]). |
429; 444; 47; 39; 44; 40 | — |
| PRIMARY Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]). |
376; 385; 34; 31 | — |
| SECONDARY Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set |
244; 272; 21; 15 | — |
| SECONDARY Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set |
248; 278; 22; 16 | — |
| SECONDARY Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT) |
361; 379; 337; 349; 340; 347 | — |
| SECONDARY Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set |
362; 379; 337; 349; 340; 347 | — |
| SECONDARY Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set. |
14; 9; 18; 12; 4; 5 | — |
| SECONDARY Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set |
39; 55; 47; 64; 1; 2 | — |
| SECONDARY Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set |
1; 2; 2; 2; 0; 1 | — |
| SECONDARY Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set |
39; 55; 7; 1; 2; 8 | — |
| SECONDARY Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry |
84; 72 | — |
| SECONDARY Plasma Concentrations for Ceftazidime and Avibactam |
50823.0; 9229.4; 40053.1; 7163.9; 10967.6; 1690.7 | — |
Summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Eligibility Criteria
Inclusion Criteria
- 18 to 90 years of age inclusive
- Female patient is authorized to participate if at least one of the following criteria are met:
- Surgical sterilization
- Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
- Age <50 years and postmenopausal as defined by documented LH and FSH levels in the postmenopausal range PLUS amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
- Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of IV study therapy
- Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
- Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
Exclusion Criteria
- Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
- Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
- Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
- Patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Data sourced from ClinicalTrials.gov (NCT01499290). 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.