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).
Current Status
Globally 27 countries, (11 COMBACTE CARE countries) are participating in the REVISIT study. Currently site initiation is underway following completion of the first in a series of virtual investigator meetings held in June 2020. First subject is expected to be enrolled into the study in August 2020.
Study team members
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Alison Luckey
EFPIA leader / Pfizer
-
Clara Rosso Fernandez
Sr. Project Manager / Academic / Virgen del Rocio University Hospital
-
Clothilde Zimmerman
Project Manager / EFPIA / Pfizer
Study level information
- Study NO NCT03329092
- Study Name REVISIT-C3601002
- Study Type Phase III
- Study Status Planned
- Enrollment Period 08/20 - 01/22
- Total subjects planned 144
- Total subjects screened 0
- Total subjects enrolled 0
- Total subjects completed 0
Study timeline
- Light blue
- Preparation phase
- Dark blue
- Trial period
Country level information
planned 15
enrolled 0
completed 0
planned 6
enrolled 0
completed 0
planned 9
enrolled 0
completed 0
planned 17
enrolled 0
completed 0
planned 4
enrolled 0
completed 0
planned 11
enrolled 0
completed 0
planned 11
enrolled 0
completed 0
planned 9
enrolled 0
completed 0
planned 28
enrolled 0
completed 0
planned 11
enrolled 0
completed 0
planned 21
enrolled 0
completed 0
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