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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02168946 | Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults | PHASE3 | COMPLETED | 77 | — | — | Jul 1, 2014 | Jul 21, 2017 | Mar 4, 2019 | 50 | United States, Argentina +6 |
Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)
Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
| Arm | Type | Description |
|---|---|---|
| Vabomere | EXPERIMENTAL | Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days |
| Best Available Therapy | ACTIVE_COMPARATOR | Subjects will receive Best Available Therapy (IV antibiotics) |
| Name | Type | Description |
|---|---|---|
| Vabomere | DRUG | Vabomere for IV injection, administered as a 2 g/2 g dose |
| Best Available Therapy | DRUG | Antibiotic(s) chosen by Investigator |
* Inclusion Criteria: 1. Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. If a subject is unable to provide informed consent due to their medical condition, the subject's legal representative will be prov...