United Kingdom
The Netherlands, Switzerland, Austria, Italy, Sweden, Denmark, France, Poland
Israel, Greece

Work package 1

Multicenter, open-label, randomized clinical trial to compare colistin alone vs. colistin plus carbapenem for severe infections caused by carbapenem-resistant bacteria.

This study will show whether the addition of meropenem is of value in the treatment of infections caused by carbapenem-resistant bacteria, and is of direct relevance for patients suffering from these life threatening conditions. The results of this trial will provide the data for the PK/PD analyses in Workpackage 4, and thereby contributing to the PK/PD analysis, setting of clinical breakpoints for colistin and provide data on safety of colistin. The microbiological package will ensure that new and relevant data will become available with respect to EDR. The correlation between the in vitro synergy studies and outcome of the patients that received the combination will, for the first time, provide data on the clinical applicability of synergy studies.

Involved institutions:
  • Radboud University Nijmegen Medical Centre (The Netherlands): Johan W Mouton (MD, PhD)
  • Tel Aviv University (Israel): Mical Paul (MD) Leonard Leibovici (MD)
  • Tel-Aviv Sourasky Medical Centre (Israel): Yehuda Carmeli (MD, MPH) 
  • University of Athens Medical School (Greece): George Petrikkos (MD, PhD) George L. Daikos (MD) Diamantis Plachouras (MD, PhD)
  • Universit√† Cattolica Sacro Cuore (Italy): Evelina Tacconelli, (MD, MS, PhD)