drugset / Trial / NCT02389036

Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients

NCT02389036

RandomizedCrossoverSingle-blindPrevention

Summary

Introduction- Hospital acquired infections (HAI) are a major cause of morbidity and mortality and increase health care costs. Critically ill patients are particularly susceptible to these infections and have an even higher mortality. One intervention that has gained much interest in the medical literature for reducing infection rates and deaths from HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of antibiotic paste to the mouth, throat, stomach and a short course of intravenous antibiotics. The evidence supporting the use of SDD for saving lives and preventing infections is actually quite strong. However, health care professionals in many parts of the world have refrained from using SDD due to fears of the effects of overuse of antibiotics on the frequency of infections with resistant bacteria such as multi-resistant Gram negative organisms, MRSA and Clostridium difficile. SuDDICU is a cross-over, cluster randomised trial comparing the effect of using selective decontamination of the digestive tract (SDD) plus standard care, to standard care alone on hospital mortality in patients receiving mechanical ventilation in the intensive care unit (ICU). Secondary outcomes include an ecological assessment and a long-term health economic analysis.

Timeline

Start
2017-05-01
Primary completion
2023-04-26
Completion
2023-04-26

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefotaxime Small molecule 1 g Intravenous
Subject Ceftriaxone Other / unclassified 1 g Intravenous
Subject Ciprofloxacin Small molecule 400 mg Intravenous
Subject Colistin Other / unclassified 10 mg Topical
Subject Colistin Other / unclassified 100 mg Other
Subject Nystatin Unknown 125000 iu Topical
Subject Nystatin Unknown 2e+06 iu Other
Subject Tobramycin Small molecule 10 mg Topical
Subject Tobramycin Small molecule 80 mg Other