At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 77 enrolled
Drug / intervention
Vabomere +1 moredrug
Likely dose
Vabomere 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multi-Center, Randomized, Open-Label Study of Vabomere(Meropenem-vaborbactam) Versus Best Available Therapy in Subjects With Selected Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)·interventional·Posted Jun 20, 2014·Updated Mar 4, 2019
In Brief
A Phase 3 clinical trial evaluating Vabomere and Best Available Therapy for Urinary Tract Infection Complicated and 5 related conditions. Completed, enrolled 77 participants across 50 sites in 8 countries.
Detailed Summary
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia, Abdominal Infection
CountriesArgentina, Brazil, Colombia, Greece, Israel, Italy, United Kingdom, United States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionJul 2017
TodayJul 2026
First PostedJun 20, 2014
Enrollment StartJul 1, 2014
Primary CompletionJul 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 12.0 years ago
Interventions
Vabomeredrug
Vabomere for IV injection, administered as a 2 g/2 g dose
Best Available Therapydrug
Antibiotic(s) chosen by Investigator