R-GNOSIS
Research type
Research Study
Full title
R-GNOSIS (Resistance in Gram-Negative Organisms: Studying Intervention Strategies) Work Package 6. Ecological effects of decolonisation in Intensive Care.
IRAS ID
174286
Contact name
Matt Wise
Contact email
Sponsor organisation
University Medical Centre Utrecht
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Infections are a major cause of morbidity and death in critical illness. Patients may be admitted to critical care with a severe infection or acquire a new infection during their stay on intensive care. Increasingly many of these infections are caused by bacteria that display resistance to the majority of antibiotics. This is particularly a problem as fewer new antibiotics are being developed and in the future patients increasingly face the prospect of developing infections for which there is no effective treatment. A number of infection prevention strategies are used worldwide to reduce the number of infections caused by multi-drug resistant gram negative bacteria (MDR GNB), but these have not been compared to one another in a trial and so it is unknown whether any particular one is superior.
The current trial will compare three infection control policies in common use to best standard care consisting of daily antiseptic body washes, oral care and a hand hygiene programme endorsed by WHO. The three policies are antibiotics in the mouth and stomach (called selective digestive decontamination - SDD), antibiotics in the mouth (called selective oral decontamination - SOD) and oral antiseptic (chlorhexidine). The study will be conducted in Europe and all eligible patients in intensive care will receive the infection control policy in any six month period. The order that the six month policy periods are undertaken will be randomised. The unit of randomisation is the intensive care population rather than individual patients and is a cluster randomised trial.REC name
Wales REC 3
REC reference
15/WA/0126
Date of REC Opinion
13 Apr 2015
REC opinion
Favourable Opinion