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COMBACTE-CARE: Meeting the challenge of carbapenem-resistant Enterobacteriaceae

COMBACTE-CARE (combatting bacterial resistance in Europe – carbapenem-resistence) 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 COMBACTE-CARE consortium brings together 18 academic medical centers and 3 pharmaceutical companies, with Pfizer operating as coordinator. This project unites the knowledge and capabilities of leading drug resistant bacterial infection experts in the field by bringing together prominent clinical and microbiology research groups in Europe to address the challenges of the observational and interventional clinical studies. The collaboration is supported by the COMBACTE clinical and laboratory networks and is developing academic research organization capability within the consortium. The consortium is collaborating with global partners such as BARDA to support global solutions.

COMBACTE-CARE aims to:

  • better understand multi-drug resistant bacterial infections such as carbapenem resistant Enterobacteriaceae (CRE) and to support the development of new treatment options;
  • analyse observational clinical and epidemiological data sets to inform the design of randomised trials;
  • make significant contributions to the development of a novel treatment option, aztreonam-avibactam (ATM-AVI), for patients with serious Gram-negative bacterial infections, including those caused by a particular type of carbapenem-resistance (metallo-β-lactamase), for which there are limited or no treatment options.

First clinical studies underway

  • EURECA – a prospective observational research assessment of the clinical management of patients with serious carbapenem-resistant Gram-negative infections. It will evaluate the risk factors for infection, current treatment options and clinical outcomes for patients with such infections across Europe;
  • REJUVENATE – which has completed patient recruitment – is a Phase II trial evaluating the pharmacokinetics and safety of ATM-AVI in patients with a complicated intra-abdominal infection (cIAI);
  • REVISIT – a phase III study, in preparation, evaluating the efficacy and safety of ATM-AVI for the treatment of serious infections due to Gram-negative bacteria, including metallo-β-lactamase producing multidrug resistant pathogens. COMBACTE-CARE is providing global medical partnership and European patient data via network and site coordination. REVISIT is also supported by the US Government’s Biomedical Advanced Research and Development Authority (BARDA) via a research agreement with Pfizer.

Management Board Members COMBACTE-CARE

5th COMBACTE General Assembly Held in Athens 82

Dr. Seamus O’Brien (Pfizer), Prof. Dr. Marc Bonten (UMC Utrecht), Prof. Dr. Jesús Rodríguez Baño

Project Management Office COMBACTE-CARE
5th COMBACTE General Assembly Held in Athens 83

From left to right: Mrs. Sophie Monteau (Servicio Andaluz de Salud), Mrs. Almudena de la Serna (Servicio Andaluz de Salud), Ms. Claire-Marie Martis (UMC Utrecht), Mrs. Elodie Pfender (CHU Limoges), Dr. Ron de Winter (UMC Utrecht), Mrs. Lisa Grimsditch (Pfizer), Dr. Ram Venkatachalam (UMC Utrecht), Mr. Craig Fisco (Pfizer)