Tel Aviv University (TAU) - Israel
Tel Aviv University is the largest university in Israel, comprising nine faculties, 106 departments, and 90 research institutes. In addition to its basic functions of research and teaching, Tel Aviv University contributes its expertise to the welfare of society at large and addresses regional and international issues. Rabin Medical Center is one of its 6 university ‐affiliated hospitals and includes 1100 beds and serves a population of about 700,000 as primary and tertiary care facility (http://www.clalit.org.il/rabin/). The hospital is the leading center in Israel for solid organ transplantation. The hospital includes a medical‐surgical intensive care unit (ICU), specialized ICUs for neurosurgery and thoracic surgery, a burn unit and a department of bone marrow transplantation.
TAU is WP‐leader for WP1 and will coordinate the clinical trial. TAU will design the protocol for the trial in collaboration with all participants and coordinate the set‐up for the trial in the individual trial sites, including the local requirements of the ethics committees. As there is considerable confusion with regard to colistin dosing and units, TAU will ensure that the same preparation is used in all sites. TAU will actively monitor the trial in the different clinical sites, to ensure that enrollment proceeds as planned and that all trial procedures are adequately followed. If one of the sites cannot recruit the planned number of patients, TAU will be responsible to recruit the alternative site as specified in the proposal. TAU will ensure uniform and full data collection at all the protocolpre‐specified time points and merge the data into a uniform database. TAU will analyze the trial results and will be responsible for publication and dissemination of the results.
Rabin Medical Center, Beilinson Hospital has ongoing prospective surveillance of carbapenem‐resistant (CR) enterobacteriaceae and other Gram‐negative bacteria. The investigators involved in the AIDA project have previously conducted clinical studies assessing the treatment of severe infections caused by multidrug‐resistant Gram‐negative bacteria, documenting the emergence and spread of A. baumannii in Israel and its associated
mortality. Comparing the effectiveness of colistin in the treatment of CR‐resistant Gram‐negative bacteria vs. that of carbapenems or ampicillin‐sulbactam for susceptible Gram‐negative bacteria, we found colistin alone to be inferior to the beta‐lactams. This study sets the background for the currently planned colistin‐imipenem combination trial in AIDA. The investigators have vast experience in evidence‐based medicine and clinical trial methods, are active within the Cochrane collaboration; and have performed more than 60 systematic reviews and meta‐analyses in the field of antibiotic treatment. We have been involved in a number of randomized controlled trials.
Prof. Leonard Leibovici (MD) is head of Medicine E at Rabin Medical Center, Beilinson Hospital, Vice Dean and Head of Medical School at Sackler Faculty of Medicine, Tel‐Aviv University. Prof. Leibovici heads the drug committee of Rabin Medical Center. He is a senior editor with the Journal of Antimicrobial Chemotherapy and was previously on the editorial board of the BMJ. He has more than 200 peer‐reviewed publications in the field of
infectious diseases, antibiotic treatment, decision support and evidence‐based medicine in journals including the JAMA, BMJ, Annals of Internal Medicine, Archives of Internal Medicine and others. Prof. Leibovici was a WP leader in the TREAT WP5 project and the coordinator of the AMICA WP6 project.
Tel Aviv University (TAU) - Israel