WP5 will evaluate the additional benefit of contact isolation (CI) compared to standard precautions (SP) in preventing the spread of ESBL-producing Enterobacteriaceae in 20 adult non-ICU wards in different European countries with universal admission and discharge screening. The study is a two-arm, cluster-randomized, controlled study (cRCT) with cross-over design. Primary outcome will be the incidence density of ESBL-acquisition.
The cRCT design and the size of the study (with approximately 40,000 patients to be included), executed in different European countries, will bring the contents of this WP beyond the state-of-the-art. Furthermore, a highly innovative technical device will be used to monitor hand hygiene frequencies. This fully automated system avoids the so-called Hawthorne effect that was present in all previous studies, in which hand hygiene compliance was determined through direct (or unobtrusive) observation of health care workers. The detailed screening for carriage will provide the necessary data to quantify species-specific reproduction rates of ESBL-producers for the first time within the frames of an international multi-centre intervention study.
The study will be performed in 4 hospitals in 4 European countries over a 31-month-period from January 2013 to July 2015.