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

Multicenter, 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.

The 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.

Each 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.

SDD 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.