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…
ID
Bron
Verkorte titel
Aandoening
Antimicrobial resistance
Infection prevention
Nosocomial infection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Study design:
This study is designed as a multicentre, cluster-randomised, cross-over study.
Study population:
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.
Intervention:
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
1. Contact isolation on a single-occupancy room;
2. Contact isolation on a multiple-occupancy room.
Publiek
M.F.Q. Kluytmans - Bergh, van den
Breda 4800 RK
The Netherlands
+31 (0)76 5953015
marjoleinkluytmans@gmail.com
Wetenschappelijk
M.F.Q. Kluytmans - Bergh, van den
Breda 4800 RK
The Netherlands
+31 (0)76 5953015
marjoleinkluytmans@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients that are hospitalised on a non-ICU, non-hemato-oncology, non-transplantation ward, and are colonised or infected with ESBL-producing Enterobacteriaceae.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2671 |
| NTR-old | NTR2799 |
| Ander register | METC St. Elisabeth Hospital : METC/jv/2010.234 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |