combacte-care News Item

Recruitment for REVISIT in Progress

Despite the impact of COVID-19 on site activation planning and sites’ ability to prioritise study activities, there has been made considerable recruitment progress over the past few months. As of January 19th, 2022, 238 subjects were randomized to the study, which is ahead of the planned number of randomized subjects by this time!

Of the 168 sites selected globally, 126 have now been activated for enrolment, 52 of which are within the COMBACTE region.  The recruitment achievements are even more impressive considering the constraints of the global pandemic and the operational hurdles our sites have overcome.  The project management team wants to give special recognition of the efforts of sites Hospital Universitario Virgen del Rocio and Hospital Universitario Reina Sofía in Spain, Karadeniz Technic University Medical Faculty in Turkey and Ivano-Frankivsk Regional Clinical Hospital  and Ivano-Frankivsk Regional Clinical Hospital in Ukraine who have so far contributed the highest number of randomizations in the COMBACTE region – thank you! The enrolment success is a team effort, and the project management team is pleased to see that of the 10 countries in the COMBACTE region that are participating, 8 countries have enrolled at least 1 subject into the REVISIT study

Over the coming weeks, the team will continue to activate the site partners around the globe and expect there will be a continued boost to enrolment as the clinical trial enters the last year of recruitment on the Phase III study. The WP2B Management Team would like to acknowledge and express their gratitude for the hard work of all site staff!

 

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.

 

Working for the REVISIT trial

The University Hospital of Virgen del Rocío (Seville, Spain) is an active site in COMBACTE-CARE. From 2016 to 2018, the hospital included patients for the Phase II REJUVENATE study. By including 20% of the total number of patient, they were the 2nd biggest site on patient including. Since 2020, the hospital includes patients for the Phase III REVISIT trial. For this trial a smooth collaboration between surgeons and the infectious disease clinical unit is needed. Read the blog in which Dr. Rosa Jiménez and Dr. Manuel Poyato show the success of Virgen del Rocío in this trial.

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