REVISIT Recruitment Continues
The recruitment in the REVISIT study continues at a solid pace with strong representation and performance of COMBACTE-CARE sites that are located in Europe. Currently 44 sites are active globally, including 24 COMBACTE-CARE sites. Since the program restart in September 2020, 33 subjects have been randomised across 19 sites of which 18 subjects were included at COMBACTE-CARE sites. This brings the total number to 40 randomised subjects since the start of REVISIT in 2018.
MORE ACTIVE SITES IN 2021
During Q1 of 2021 and with the gradual relief of local constraints due to the pandemic, the planning is to activate 21 more sites globally. This will be heralded with upcoming series of 3 regional virtual Investigator Meetings being planned during March 2021.
The COMBACTE WP2B Management Team continues to offer support to sites at a global level, with active participation in the monthly Open Forum (‘drop-in sessions’) and provision of medical monitoring activities including through the Academic Lead 24/7 telephone support line.
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The study team would like to thank all sites for their ongoing commitment to the program and look forward to sharing the continued successes over the coming months.
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...
