Ecological Effects of Decolonisation Strategies in Intensive Care

PHASE3CompletedINTERVENTIONAL
Enrollment

8,665

Participants

Timeline

Start Date

December 1, 2013

Primary Completion Date

October 27, 2017

Study Completion Date

October 27, 2017

Conditions
ICU-ecology (Multidrug Resistant Bacteria)ICU-acquired Bacteraemia
Interventions
DRUG

Chlorhexidine oral care (CHX-Oro)

Oromucosal gel consisting of chlorhexidine 1%, administered 4 times daily.

DRUG

Selective oropharyngeal decontamination (SOD)

SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10\^5 units. SOD will be applied to the mouth 4 times daily until extubation.

DRUG

Selective Digestive Decontamination (SDD)

"SDD consists of both:~* SOD (described elsewhere)~* AND 10 ml of an enteric suspension containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10\^6 i.u, to be administered via the nasogastric tube.~The combination is administered 4 times daily (Unlike in previous studies, systemic antibiotics are not a part of SDD)"

Trial Locations (13)

340

Clinique Saint-Pierre Ottignies, Ottignies

4000

CHU Liege, Liège

4204

University clinic of respiratory and allergic diseases, Golnik

9000

Algemeen Ziekenhuis Sint Lucas, Ghent

Universitair Ziekenhuis Gent, Ghent

46026

Hospital Universitario y Politécnico La Fé de Valencia, Valencia

B-2650

Universitair Ziekenhuis Antwerpen, Edegem

00152

Ospedale San Camillo, Rome

4099-001

Hospital Geral de Santo António (Centro Hospitalar do Porto, EPE), Porto

5000 - 508

Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE, Vila Real

08036

Hospital Clinic of Barcelona, Barcelona

08041

l'Hospital de la Santa Creu i Sant Pau, Barcelona

CF14 4XW

University Hospital of Wales, Cardiff

All Listed Sponsors
collaborator

Paris 12 Val de Marne University

OTHER

lead

MJM Bonten

OTHER

NCT02208154 - Ecological Effects of Decolonisation Strategies in Intensive Care | Biotech Hunter | Biotech Hunter