First Subject First Visit
The WP2B Management Team are pleased to announce achievement of First Subject First Visit in the Aztreonam-Avibactam REVISIT study, at site #1176 (Czech Rep), on 02 Sep 2020. Site initiation visits continue to be rolled out, with 16 sites currently activated globally.
We also see the launch of the 24/7 telephone investigator support line for the C3601002 (REVISIT) Study. This service is an example of the unique public-private collaboration in action and facilitates provision of expert scientific and medical support to investigators participating in the study globally. The Academic Leads will, through this service, provide medical monitoring activities throughout the enrollment period of the study to address questions and concerns relating to eligibility of potential subjects with the aim of supporting sites to enroll appropriate subjects and in the delivery of high quality data into the program.
Investigator Meetings
The restart of the ATM-AVI Phase 3 REVISIT study commenced on 18 June 2020, with the first of a series of virtual REVISIT Investigator Meetings. The meeting saw most of the selected investigating sites from the COMBACTE-CARE region participating, and represents a new, adaptive approach to site training.
About REVISIT
Determining efficacy and safety of ATM-AVI for treating serious infections caused by Gram-negative, carbapenem-resistant, bacteria. 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.
The phase II REJUVENATE project (WP2A) reported the PK and safety of ATM-AVI in a representative patient population and confirmed the dose regime for Phase III program.
WP2B is a pivotal regulatory submission global phase III study (REVISIT) which will further establish 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 this study in co-development with AbbVie (formerly Allergen) and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA).
Related updates
EMA recommends Marketing Authorization for ATM-AVI
Pfizer Receives Positive CHMP Opinion for its Novel Antibiotic Combination for the Treatment of Patients with Multidrug-Resistant Infections and Limited Treatment Options
COMBACTE is proud to announce a significant milestone achieved in COMBACTE-CARE. The European Medicines Agency (EMA) has recommended granting a market...
