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. WP2B 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.

Determining efficacy and safety

In the Phase II REJUVENATE project (WP2A), the pharmacokinetics and safety of ATM-AVI are being investigated. In WP2B this research has progressed into a Phase III clinical trial (REVISIT) to determine the efficacy and safety of treating a representative population of serious Gram-negative bacterial infections with ATM-AVI.

Regulatory approval

Pfizer, as sponsor, and COMBACTE-CARE via WP2B are conducting a global study in partnership with, and co-funded by the US Biomedical Advanced Research and Development Authority (BARDA). REVISIT will be a pivotal Phase III study for the ATM-AVI regulatory submission package.

Current status

Globally 27 countries, 11 in Europe are participating in the REVISIT study. Regulatory and Ethics submissions are ongoing in most of the countries. To date, Clinical Trial Application approvals have been obtained in 10 countries globally, including 4 in Europe, and the study is now entering the patient randomization phase.

* Recruitment has been temporarily suspended in study C3601002 due to a delay in investigational product availability.  Revised study timelines to be posted upon IMI approval.