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van CCT (UK)

The effects of SDD and SOD on antibiotic resistance in the ICU.

- candidate number5664
- NTR NumberNTR1780
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2009
- Secondary IDs08/097 MEC UMC
- Public TitleThe effects of SDD and SOD on antibiotic resistance in the ICU.
- Scientific TitleThe effects of SDD and SOD on antibiotic resistance in the ICU: A multi-center comparison.
- hypothesisThe difference between both interventions is the absence of intestinal decontamination during SOD and the standard use of cephalosporins for all patients during SDD. It has been hypothesized that eradication of the intestinal Gram negative bacterial flora reduces the likelihood of resistance development in Gram negative bacteria.
- Healt Condition(s) or Problem(s) studiedAntimicrobial resistance, SDD, SOD
- Inclusion criteriaPatients admitted to ICU with an expected length of ICU stay of 48 hours.
- Exclusion criteriaPatients younger than 18 years.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate31-mrt-2012
- Target number of participants6000
- InterventionsSDD consists of an oropharyngeal application (every 6 h) of a paste containing colistine, tobramycin and amphotericin B each in a 2% concentration, and administration (every 6 h) of a 10 ml suspension containing colistine, tobramycin and amphotericin B via the nasogastric tube. Topical antibiotics will be applied until ICU-discharge. In addition, cefotaxime (1000 mg, every 6 h) will be administered intravenously during the first four days of study. SOD consists of oropharyngeal application of the same paste as used for SDD.
- Primary outcomePoint prevalence of rectal and respiratory colonization with specificantly defined resistant bacteria (both Gram positive and Gram negative) according to the WIP-guidelines.
- Secondary outcome1. ICU-admission until 48 hours after ICU-discharge, and microbiologically documented;
2. Rate of ICU-acquired bacteraemia caused by antibiotic resistant bacteria, expressed as the rate per 100 ICU-acquired bacteraemia caused by all pathogens;
3. Mortality; at day 28, ICU- and in-hospital mortality;
4. Length of ICU-stay;
5. Predefined subgroup analysis: mortality (28 days-, IC- and in-hospital mortality) in two subgroups: surgical and non-surgical patients;
6. Annual use of antibiotics based on pharmacy records.
- TimepointsEach ICU will be randomized into one of two study arms, starting either with SDD or SOD for twelve months, with cross-over to the other intervention. Before starting the first study period and after the first period, a wash-out wash-in period (1 month) will be carried out, during which the new treatment (either SDD or SOD) will be implemented, but patient data will not be used for analysis.
- Trial web
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryMulticenter, cross-over comparison study of SDD and SOD in ICU settings using either SDD or SOD for standard care. Results from routinely performed clinical and surveillance cultures will be used to assess development of antibiotic resistance in different ‘marker’ pathogens.
- Main changes (audit trail)
- RECORD28-apr-2009 - 23-sep-2009

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