Celebrating Success: Major Achievement in COMBACTE-CARE

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REVISIT Virtual Investigator Meetings

The much-anticipated restart of the ATM-AVI Phase 3 REVISIT study commenced on 18 June 2020, with the first of what will be a series of virtual REVISIT Investigator Meetings. The meeting saw most of the selected investigating sites from the COMBACTE-CARE region participating and represents a new, adaptive approach to site training.

The meeting was followed on 25 June 2020, by the first Site Initiation Visit (SIV) and our thanks goes to Principal Investigator, Dr Michal Hanauer at Site # 1176, (Czech Republic) for his support in enabling us to achieve this important milestone. This was closely followed by SIVs on 29 June 2020 at Site # 1133 (Dr Rosa Jiménez Rodrigues, Spain) and Site # 1218 (Dr Georgi Arabadzhiev, Bulgaria).

Further virtual Investigator Meetings and Site Initiation Visits are to be rolled out globally over the coming weeks and months.

REVISIT Study

The WP2B Management Team would like to thank all site staff for their continued commitment to the REVISIT study and particularly their willingness to engage with site initiation activities during the emerging COVID-19 pandemic. This acknowledges, now more than ever, the importance placed on advancing research into new therapies in the area of antimicrobial resistance.

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.
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.

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