Dirty mouth? Should you clean it out? Decontamination for the prevention of pneumonia and mortality in the ICU

Background\ud Selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SOD) are infection-prevention measures used in the treatment of some patients in intensive care, but reported effects on patient outcome are conflicting.\ud \ud Methods\ud Objective: To evaluate the effectiveness of SDD and SOD in intensive care unit (ICU) patients.\ud \ud Design\ud A controlled, crossover study using cluster randomization.\ud \ud Setting\ud 13 ICUs in the Netherlands between May 2004 and July 2006.\ud \ud Subjects\ud 5939 patients with an expected duration of intubation of more than 48 hours or an expected ICU stay of more than 72 hours were eligible.\ud \ud Intervention\ud In each ICU, three regimens (SDD, SOD, and standard care) were applied in random order over the course of 6 months. SDD consisted of 4 days of intravenous cefotaxime and topical application of tobramycin, colistin, and amphotericin B in the oropharynx and stomach. SOD consisted of oropharyngeal application only of the same antibiotics.\ud \ud Outcomes\ud Mortality at day 28 was the primary end point. Monthly point-prevalence studies were performed to analyze antibiotic resistance.\ud \ud Results\ud A total of 5939 patients were enrolled in the study, with 1990 assigned to standard care, 1904 to SOD, and 2045 to SDD; crude mortality in the groups at day 28 was 27.5%, 26.6%, and 26.9%, respectively. In a random-effects logistic-regression model with age, sex, Acute Physiology and Chronic Health Evaluation (APACHE II) score, intubation status, and medical specialty used as covariates, odds ratios for death at day 28 in the SOD and SDD groups, as compared with the standard-care group, were 0.86 (95% confidence interval [CI], 0.74 to 0.99) and 0.83 (95% CI, 0.72 to 0.97), respectively.\ud \ud Conclusions\ud In an ICU population in which the mortality rate associated with standard care was 27.5% at day 28, the rate was reduced by an estimated 3.5 percentage points with SDD and by 2.9 percentage points with SOD. (Controlled Clinical Trials number, ISRCTN35176830.