Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
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
- Results Cuthbertson BH, Campbell MK, MacLennan G, Duncan EM, Marshall AP, Wells EC, Prior ME, Todd L, Rose L, Seppelt IM, Bellingan G, Francis JJ. Clinical stakeholders' opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study. Crit Care. 2013 Nov 8;17(6):R266. doi: 10.1186/cc13096.
- Results Daneman N, Sarwar S, Fowler RA, Cuthbertson BH; SuDDICU Canadian Study Group. Effect of selective decontamination on antimicrobial resistance in intensive care units: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Apr;13(4):328-41. doi: 10.1016/S1473-3099(12)70322-5. Epub 2013 Jan 25.
- Results Cuthbertson BH, Francis J, Campbell MK, MacIntyre L, Seppelt I, Grimshaw J; SuDDICU study groups. A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (the SuDDICU study). Trials. 2010 Dec 3;11:117. doi: 10.1186/1745-6215-11-117.
- SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group; Cuthbertson BH, Billot L, Campbell MK, Daneman N, Davis JS, Delaney A, Devaux A, Ferguson ND, Finfer SR, Fowler R, Gordon AC, Hammond NE, Klein G, Li Q, Marshall J, Micallef S, Murthy S, Mysore J, Naik C, Patel C, Pinto R, Rose L, Seppelt IM, Venkatesh B, Young PJ, Myburgh JA; The SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group. Selective Decontamination of the Digestive Tract during Ventilation in the ICU. N Engl J Med. 2026 Apr 16;394(15):1491-1502. doi: 10.1056/NEJMoa2506398. Epub 2025 Oct 29.
- Billot L, Cuthbertson B, Gordon A, Al-Beidh F, Correa M, Davis J, Finfer S, Glass P, Goodman F, Hammond N, Iredell J, Miller J, Murthy S, Rose L, Seppelt I, Taylor C, Young P, Myburgh J; SuDDICU Investigators. Protocol summary and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) crossover, cluster randomised controlled trial. Crit Care Resusc. 2023 Oct 18;23(2):183-193. doi: 10.51893/2021.2.oa5. eCollection 2021 Jun.
- Young PJ, Devaux A, Li Q, Billot L, Davis JS, Delaney A, Finfer SR, Hammond NE, Micallef S, Seppelt IM, Venkatesh B, Myburgh JA; SuDDICU Australia Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Selective digestive tract decontamination in critically ill adults with acute brain injuries: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Jan;50(1):56-67. doi: 10.1007/s00134-023-07261-y. Epub 2023 Nov 20.
- SuDDICU Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group; Myburgh JA, Seppelt IM, Goodman F, Billot L, Correa M, Davis JS, Gordon AC, Hammond NE, Iredell J, Li Q, Micallef S, Miller J, Mysore J, Taylor C, Young PJ, Cuthbertson BH, Finfer SR. Effect of Selective Decontamination of the Digestive Tract on Hospital Mortality in Critically Ill Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2022 Nov 15;328(19):1911-1921. doi: 10.1001/jama.2022.17927.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |