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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01265784 | Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections | PHASE2 | COMPLETED | 143 | — | — | Jan 1, 2011 | May 1, 2012 | Jan 6, 2022 | 38 | United States, Bulgaria +4 |
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason).
| Arm | Type | Description |
|---|---|---|
| TP-434, 1.5 mg/kg q24h | EXPERIMENTAL | TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| TP-434, 1.0 mg/kg q12h | EXPERIMENTAL | TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Ertapenem, 1 g q24h | ACTIVE_COMPARATOR | Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Name | Type | Description |
|---|---|---|
| TP-434 | DRUG | - |
| Ertapenem | DRUG | - |
| Placebo | DRUG | Administered IV to maintain the blind. |
Inclusion Criteria: * Abdominal pain/discomfort with onset prior to hospitalization * Evidence of a systemic inflammatory response * Physical findings consistent with intra-abdominal infection (IAI) * Clinical diagnosis of community-acquired IAI requiring urgent surgical or percutaneous interventio...