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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01147640 | Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections | PHASE2 | COMPLETED | 122 | — | — | Jun 25, 2010 | Mar 25, 2011 | Oct 25, 2018 | 33 | United States, Argentina +3 |
Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
| Arm | Type | Description |
|---|---|---|
| CXA 101/tazobactam and metronidazole | EXPERIMENTAL | - |
| meropenem with matching saline placebo | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CXA-101/ tazobactam and metronidazole | DRUG | CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion |
| meropenem plus saline placebo | DRUG | meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion |
Inclusion Criteria: * Male or female, from 18 to 90 years of age, inclusive * One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond t...