REVISIT Investigator Meeting, Madrid

On the 24th of April, an investigator meeting for the REVISIT study (supported by the IMIJU, BARDA and Pfizer) was held in Madrid, right after ECCMID 2018 came to an end. COMBACTE-CARE is responsible for significant Global clinical leadership and European conduct of REVISIT.

The goal of the meeting was to introduce ATM-AVI and the REVISIT study to our investigative sites and provide training on the protocol, study systems and Good Clinical Practice.

The meeting overall was led by the Pfizer ATM-AVI clinical team with strong support for individual sessions from COMBACTE-CARE academic leads (Dr. Yehuda Carmelli, Dr. George Daikos and Dr. Jose Miguel Cisneros Herreros), the CLIN-Net team and PAREXEL as the global CRO.  This is one of three regional meetings being held for REVISIT.   The Americas region will be held at the end of May in Buenos Aires, Argentina. The Asia-Pacific region will be held in early June in Cambodia.

192 attendees from 12 countries (EU, including Spain, Ukraine, Croatia, Hungary, Bulgaria, Turkey, Greece, Czech Republic, Romania, Russia, Israel and South Africa) attendended the REVISIT Investigator Meeting. The General Session consisted of 18 presentations including timeline review, protocol training, laboratory training, audit and inspection readiness and site expectations, including recruitment, data management and monitoring.

On Day 2, the management team met with the Clinical Research Associates and Regional Clinical Site Leads to further detail out the protocol and monitoring expectations.

The REVISIT Study has so far selected 52 sites in 9 European countries including Israel, Russia and South Africa with 9 out of 10 backup sites confirmed in the last two weeks. The meeting concluded with a team dinner and successful review of the objectives and next steps to start up in the COMBACTE-CARE/European region.

Expectations are site initiations will begin in June and enrollment commencing shortly thereafter. The meeting was successful in providing training to all selected sites. There were no major updates to the protocol post meeting however clarifications were made to allow sites to conduct the study more closely aligned to their standard of care.