ANZICS CTG Endorsed Study
A crossover, cluster randomised controlled trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit patients.
Selective Decontamination of the Digestive Tract (SDD) is a treatment designed to reduce the risk of infection and improve survival for critically ill patients, involving the application of topical non-absorbable antibiotics and antifungals to the throat and instillation into the stomach, combined with a short course of intravenous antibiotics. Although many trials suggest that SDD works, the research results have not been convincing enough to lead to the widespread uptake of SDD. Clinicians are concerned that SDD will increase antibiotic resistance and as a result, SDD is not currently widely practiced.
This study was designed to resolve this uncertainty. We planned to conduct a crossover cluster randomised controlled trial (x-cRCT) for two 12-month periods in about 30 ICUs in Australia, Canada and UK, recruiting about 12,000 mechanically ventilated patients. Mortality rates would be compared between the two groups and antibiotic resistance rates evaluated in samples from all patients in the ICUs prior, during and after the trial.
This trial addresses a fundamental question in intensive care medicine – does SDD reduce critically ill patients’ risk of dying without increasing antibiotic resistance rates? If SDD is found to be effective without increasing antibiotic resistance, the study will have a global impact, leading to improved survival and reduced infection rates in critically ill patients. The results of this study will change practice and be of immense value to clinicians, policy makers and regulators.
John Myburgh, Ian Seppelt, Simon Finfer, Brian Cuthbertson, Laurent Billot, Jon Iredell, Jennene Miller, Colman Taylor, Joshua Davis, Paul Young, Fiona Goodman and Naomi Hammond
The George Institute for Global Health
NHMRC, National Health and Medical Research Council, CIHR
CTG1718-01, ACTRN12615000411549, NCT02389036
Ian Seppelt (email)