CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20,010 enrolled
Drug / intervention
SDD Oral Paste +2 moredrug
Likely dose
SDD Oral Paste 0.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02389036
NCT02389036Phase 3Completed

A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)

The George Institute·interventional·Posted Mar 17, 2015·Updated Aug 14, 2023

In Brief

A Phase 3 clinical trial evaluating SDD Oral Paste, SDD Gastric Suspension, and 1 other intervention for Critical Illness and 3 related conditions. Completed, enrolled 20,010 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, United Kingdom

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 17, 2015
Enrollment StartMay 1, 2017
Primary CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 11.3 years ago

Interventions

SDD Oral Pastedrug

A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx

SDD Gastric Suspensiondrug

2\. A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 10 \^6 IU nystatin, to the gastrointestinal tract via a gastric/post-pyloric tube

Intravenous Antibioticdrug

A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic