COMBACTE-CARE Project Update
We are delighted to share with you the Innovative Medicines Initiative (IMI)’s approval of the COMBACTE-CARE project extension from 29th February 2020 until 31st December 2022. This extraordinary extension of 34 months demonstrates the importance of our project in the fight against antimicrobial resistance (AMR) and the level of commitment from IMI in supporting delivery of the project objectives.
Pfizer paused progression of the ATM-AVI REVISIT study (C3601002) in August 2018 due to an issue with availability of clinical trial supplies. This issue has now been resolved and we are pleased to announce that the team is preparing to restart the study and has informed investigators. Clinical Trial Application amendments are being resubmitted to regulatory authorities globally. The next regional investigator meeting is currently scheduled for 13-15 May 2020 in Barcelona and site initiation visits for European sites will start shortly thereafter. We look forward to resuming this critical study as soon as possible.
About COMBACTE-CARE
COMBACTE-CARE (Carbapenem Resistance) is meeting the challenge of carbapenem-resistant Gram-negative bacteria. In time, our current assortment of antibiotics no longer suffices. This project counters that threat by laying the groundwork for tests of new and more effective treatments.
The aims of COMBACTE-CARE are to better understand current clinical management and outcomes of hospitalized patients with carbapenem resistant Enterobacteriaceae (CRE) infections, to analyse clinical and microbiological data to provide new insights for novel clinical trial designs, and to make recommendations for the development of novel antibiotics to treat resistant infections.
About REVISIT
REVISIT: a global, phase III clinical trial designed to evaluate the safety, efficacy and tolerability of ATM-AVI for the treatment of serious infections due to gram-negative bacteria including metallo-beta-lactamase (MBL) producing MDR pathogens, for which there are limited or no treatment options.
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.
Related updates
EMA recommends Marketing Authorization for ATM-AVI
Pfizer Receives Positive CHMP Opinion for its Novel Antibiotic Combination for the Treatment of Patients with Multidrug-Resistant Infections and Limited Treatment Options
COMBACTE is proud to announce a significant milestone achieved in COMBACTE-CARE. The European Medicines Agency (EMA) has recommended granting a market...
