A Phase 3, Multi-Center, Randomized, Open-Label Study of Carbavance (Meropenem/Vaborbactam) Versus Best Available Therapy in Subjects With Selected Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Phase of Trial: Phase III
Latest Information Update: 10 Aug 2017
At a glance
- Drugs Meropenem/vaborbactam (Primary)
- Indications Enterobacteriaceae infections
- Focus Registrational; Therapeutic Use
- Acronyms TANGO 2
- Sponsors Rempex Pharmaceuticals; The Medicines Company
- 06 Aug 2017 Status changed from recruiting to completed.
- 25 Jul 2017 According to The Medicines Company media release, the study protocol will be amended to now enroll patients only into the meropenem-vaborbactam treatment group.
- 25 Jul 2017 According to The Medicines Company media release, the DSMB concluded that a risk-benefit analysis of available data no longer supported randomization of additional patients to the best available therapy comparator arm. The Company will continue to enroll patients into an amended, single-arm study protocol for treatment with meropenem-vaborbactam at selected sites.