|- candidate number||9200|
|- NTR Number||NTR2799|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mrt-2011|
|- Secondary IDs||205100010 ZonMw|
|- Public Title||Single- or Multiple-occupancy room isolation of patients colonised with ESBL-producing Enterobacteriaceae.|
|- Scientific Title||Single- or Multiple-occupancy room isolation of patients colonised with ESBL-producing Enterobacteriaceae: A multicentre cluster-randomised study (SoM-study).|
|- hypothesis||The primary objective of this study is to demonstrate that contact isolation of patients colonised with ESBL-producing Enterobacteriaceae in a multiple-occupancy room is not inferior to contact isolation in a single-occupancy room with respect to the horizontal transmission of ESBL-producing Enterobacteriaceae to other hospitalised patients.|
|- Healt Condition(s) or Problem(s) studied||Nosocomial infections, Infection prevention, Antimicrobial resistance|
|- Inclusion criteria||Patients that are hospitalised on a non-ICU, non-hemato-oncology, non-transplantation ward, and are colonised or infected with ESBL-producing Enterobacteriaceae.|
|- Exclusion criteria||1. Patients with an age of less than 18 years;|
2. Patients who refuse or are unable to give permission for using patient-specific data;
3. Patients that are known to be colonised or infected with a microorganism that requires isolation in a single room, e.g. highly resistant Acinetobacter spp., highly resistant Streptocococcus pneumoniae, highly resistant Enterococcus faecium, MRSA, and (multiresistant) Mycobacterium tuberculosis;
4. Patients that are colonised or infected with ESBL-producing Enterobacteriaceae of the same* species and with the same antibiogram as that of an isolate that has been detected previously in clinical cultures of previously included index patients or ward mates that are at that moment still hospitalised on the same ward.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||31-jul-2012|
|- Target number of participants||592|
|- Interventions||1. Contact isolation on a single-occupancy room;|
2. Contact isolation on a multiple-occupancy room.
|- Primary outcome||The transmission rate of ESBL-producing Enterobacteriaceae, i.e. the proportion of index patients in which transmission of ESBL-producing Enterobacteriaceae to a ward mate occurs.|
|- Secondary outcome||1. The transmission rate of mobile genetic elements harbouring resistance genes that encode for ESBL, i.e. the proportion of index patients in which transmission of mobile genetic elements to a ward mate occurs;|
2. The occurrence of ESBL-producing Enterobacteriaceae in clinical cultures from hospitalised patients;
3. The prevalence of colonisation with ESBL-producing Enterobacteriaceae in hospitalised patients;
4. All-cause mortality at 28 days and after 6 months.
|- Timepoints||1. 7 days: Prevalence of colonisation with ESBL-producing Enterobacteriaceae, including presence of resistance genes;|
2. Admission until discharge: Infection with ESBL-producing Enterobacteriaceae;
3. 28 days: All-cause mortality;
4. 6 months: All-cause mortality.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. MSc. M.F.Q. Kluytmans - Bergh, van den|
|- CONTACT for SCIENTIFIC QUERIES||Prof.dr. J.A.J.W. Kluytmans|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objectives: |
The primary objective of this study is to demonstrate that contact isolation of patients colonised with ESBL-producing Enterobacteriaceae in a multiple-occupancy room is not inferior to contact isolation in a single-occupancy room with respect to the horizontal transmission of ESBL-producing Enterobacteriaceae to other hospitalised patients.
The secondary objectives pertain not only to the comparison of the two isolation strategies, but also to the prevalence and follow-up data, the clinical culture data and the development of microbiological methods.
This study is designed as a multicentre, cluster-randomised, cross-over study.
1. Participating centres: University, teaching or general hospitals;
2. Index patients: Patients with an age ≥ 18 years, that are hospitalised on a non-ICU, non-hemato-oncology, non-transplantation ward, and are colonised or infected with ESBL-producing Enterobacteriaceae;
3. Ward mates: Patients that are hospitalised on the index ward on day 7 (+/-2) after inclusion of the index patient.
Two isolation strategies will be compared in this study:
1. Contact isolation in a single-occupancy room;
2. Contact isolation in a multiple-occupancy room.
The two isolation strategies will be performed in two consecutive periods, where the order is randomly assigned to the participating centres.
Primary study endpoint:
The primary endpoint of this study is the transmission rate of ESBL-producing Enterobacteriaceae.
|- Main changes (audit trail)|
|- RECORD||4-mrt-2011 - 16-mrt-2011|