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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02070757 | Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) | PHASE3 | COMPLETED | 726 | — | — | Sep 2, 2014 | Jun 6, 2018 | May 5, 2020 | - | — |
To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia \[VABP\] or ventilated hospital-acquired bacterial pneumonia \[HABP\]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
| Arm | Type | Description |
|---|---|---|
| Ceftolozane/tazobactam | EXPERIMENTAL | Participants receive 3000 mg ceftolozane/tazobactam intravenous IV (comprising 2000 mg ceftolozane and 1000 mg tazobactam) every 8 hours for 8-14 days. |
| Meropenem | ACTIVE_COMPARATOR | Participants receive 1000 mg meropenem IV every 8 hours for 8-14 days. |
| Name | Type | Description |
|---|---|---|
| Ceftolozane/tazobactam | DRUG | Ceftolozane/tazobactam is an antibacterial consisting of a co-formulation of ceftolozane, a novel antipseudomonal cephalosporin and tazobactam, a well-established beta (β)-lactamase inhibitor (BLI) being developed for the treatment of serious bacterial infections. |
| Meropenem | DRUG | Meropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia. |
Key Inclusion Criteria: * Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy; * Intubated and on mechanical ventilation at the time of randomization; * New or progressive infiltrate on chest radiography consistent with pneumonia; * Presence of clinical ...