COMBACTE-CARE's REVISIT trial has now up to 376 subjects randomized. The program has elected to increase the target number of subjects randomized from 375 to up to approximately 425 to ensure adequate patient numbers in the Phase III program to support the global submissions.
Of the 142 sites selected globally, 138 have now been activated for enrolment, 68 of which are within the COMBACTE region. 37 of those 68 sites have randomized at least 1 patient since their site activation. The recruitment achievements are even more impressive considering the constraints of the global pandemic and the operational hurdles our sites have overcome.
Special recognition of the efforts goes to sites 1133 (n=14) and 1135 (n=19) in Spain, site 1143 (n=10) in Turkey, and sites 1207 (n=17) and 1247 (n=16) in Ukraine who have so far contributed the highest number of enrolments in the COMBACTE region. The enrolment success is a team effort, and the study team is pleased to see such active participation across all of our dedicated COMBACTE-CARE sites.
Over the coming weeks, the team will continue to push to meet the recruitment goals this year in anticipation of closing the study in 2023. The WP2B Management Team would like to acknowledge and express their gratitude for the hard work of all site staff during these difficult times.
About REVISIT (WP2B)
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).