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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02493764 | Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) | PHASE3 | COMPLETED | 537 | — | — | Nov 24, 2015 | Apr 3, 2019 | Apr 16, 2020 | - | — |
The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.
| Arm | Type | Description |
|---|---|---|
| IMI/REL | EXPERIMENTAL | Imipenem 500 mg + relebactam 250 mg + cilastatin 500 mg as a FDC administered intravenously (IV) every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. |
| PIP/TAZ | ACTIVE_COMPARATOR | Piperacillin 4000 mg + tazobactam 500 mg as a FDC administered IV every 6 hours for a minimum of 7 days, up to 14 days. At study entry open label linezolid 600 mg will also be administered by IV every 12 hours for up to 14 days. |
| Name | Type | Description |
|---|---|---|
| Imipenem | DRUG | Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days |
| Relebactam | DRUG | Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days |
| Cilastatin | DRUG | Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days |
| Piperacillin | DRUG | Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days |
| Tazobactam | DRUG | Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days |
| Linezolid | DRUG | Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days |
Inclusion Criteria: * Requires treatment with IV antibiotic therapy for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) * Fulfills clinical and radiographic criteria, with onset of criteria occurring after more than 48 hours of hospitalization or wit...