In early 2018 COMBACTE-CARE’s REVISIT (WP2B) study had a timely site initiation in Turkey and the United States.
The site initiation included a strong start to recruitment in one US site (FSFV April 2018); however, due to supply interruptions further enrolment has been delayed. The team is working diligently to progress the study and expects to recommence enrollment for this important program in Q1 2020.
REVISIT will begin with refresher trainings during a series of planned regional investigator meetings and is now expected to recommence enrolment for this important program in Q1 2020.
REVISIT – Revisiting serious bacterial infection with innovation – is conducting a Phase III randomized, open-label, comparative clinical trial to determine the efficacy and safety of aztreonam-avibactam (ATM-AVI). ATM-AVI is intended for treating serious bacterial infections caused by Gram-negative bacteria, including metallo-beta-lactamase-producing MDR pathogens, for which there are limited or no treatment options.
In the Phase II REJUVENATE project (WP2A), the pharmacokinetics and safety of ATM-AVI are being investigated. In WP2B this research has progressed into a Phase III clinical trial (REVISIT) to determine the efficacy and safety of treating a representative population of serious Gram-negative bacterial infections with ATM-AVI.
Pfizer, as sponsor, and COMBACTE-CARE via WP2B are conducting a global study in partnership with, and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA). REVISIT will be a pivotal Phase III study for the ATM-AVI regulatory submission package.