High Recruitment Achievements in REVISIT

The impact of COVID-19 on site activation planning and sites’ ability to prioritise study activities are beginning to subside, despite some regional variances. Of the 173 sites selected globally, 110 have now been activated for enrolment, 80 of which are within the COMBACTE region.

As of the end of September 2021, a total of 138 subjects have been randomised globally, almost double compared to the beginning of June 2021. This indicates that of those sites that are active and have current capacity to enrol, engagement with and activity on the study is high. The recruitment achievements are even more impressive considering the constraints of the global pandemic and the operational hurdles the sites have overcome.

The team especially wants to recognize the efforts of Hospital Universitario Virgen del Rocio (Site 1133, n=9) and Hospital Universitario Reina Sofia (Site 1135, n=9) in Spain and and Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova in Ukraine (Site 1247, n=10) have so far contributed the highest enrolment in the COMBACTE region – a great milestone.

Over the coming weeks, the team will continue to activate site partners around the globe and expect there will be a boost to current enrolment figures into 2022. The team continues to execute a number of site support initiatives, training, and ongoing feasibility/site selection in order to drive enrolment and minimise delays to the program.

The REVISIT Management Team would like to acknowledge and express their gratitude for the site staff’s hard work during these difficult times.

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).