ANZICS CTG Endorsed Study

SuDDICU

A crossover, cluster randomised controlled trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit patients in Australia and New Zealand
(was the ANZICS CTG Supported SuDDICU-ANZ CTG1314-13)

Study Description

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 deliberate application of antibiotics and antifungal drugs to the throat and their 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 amongst endemic bacteria. As a result, SDD is not currently widely practiced.

This study is designed to resolve this uncertainty. We will conduct a crossover cluster randomised controlled trial (x-cRCT) for two 12 month periods in about 20 ICUs in Australia and NZ., recruiting about 6,900 critically ill mechanically ventilated patients. Mortality rates will be compared between the two groups and antibiotic resistance levels will be evaluated in samples from all patients prior to, during, and after the trial.

This trial will address 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.

Management Committee

John Myburgh, Ian Seppelt, Farah Al-Beidh, Laurent Billot, Brian Cuthbertson, Maryam Correa, Joshua Davis, Simon Finfer, Parisa Glass, Fiona Goodman, Anthony Gordon, Jon Iredell, Stephen Jan, Coleman Taylor, and Paul Young.

Administering Institution

The George Institute for Global Health

Collaborators

Anthony Gordon (UK Intensive Care Trials Group).

Sample Size

>10,000 in x-cRCT internationally

Funding

NHMRC $3.96 million
NHMRC [metagenomic and resistance substudy] A$901k
CIHR C$3m.

Project Status as of June 2018

SuDDICU is now up and running in Australia and recruiting well as sites come online. It is anticipated that all sites will be in the first intervention phase by January 2019. Despite significant delays related to study drug development and testing, and international funding, the SuDDICU Management Team is now extremely happy with the progress of this trial. It is anticipated that Canadian and British sites will commence recruitment in 2019, leading to an expected completion date in 2021 and final results for the trial in early 2022.

Contact

Ian Seppelt (mail)

Reference

CTG1718-01
ACTRN12615000411549
NCT02389036 (ClinicalTrials.gov)