Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01499290 | Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections | PHASE3 | COMPLETED | 493 | — | — | Mar 1, 2012 | Apr 1, 2014 | Sep 6, 2017 | 56 | United States, Argentina +18 |
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.
The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
| Arm | Type | Description |
|---|---|---|
| CAZ-AVI + Metronidazole | EXPERIMENTAL | IV treatment |
| Meropenem | ACTIVE_COMPARATOR | IV treatment |
| Name | Type | Description |
|---|---|---|
| CAZ-AVI | DRUG | Ceftazidime 2000 mg and 500 mg of avibactam |
| Metronidazole | DRUG | 500 mg of Metronidazole |
| Meropenem | DRUG | 1 gram of Meropenem |
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: 1. Surgical sterilization 2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogeno...