Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct 18;23(2):183-193.
doi: 10.51893/2021.2.oa5. eCollection 2021 Jun.

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

Laurent Billot  1   2 , Brian Cuthbertson  1   3 , Anthony Gordon  1   4 , Farah Al-Beidh  4 , Maryam Correa  1 , Joshua Davis  5 , Simon Finfer  1   2   6   7 , Parisa Glass  1 , Fiona Goodman  1 , Naomi Hammond  1   2   6 , Jonathon Iredell  7   8 , Jennene Miller  9 , Srinivas Murthy  10 , Louise Rose  11 , Ian Seppelt  1   7   12 , Colman Taylor  1   2 , Paul Young  13   14 , John Myburgh  1   2   9 ; SuDDICU Investigators
Affiliations

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

Laurent Billot et al. Crit Care Resusc. .

Abstract

Background: It is unclear whether the use of selective decontamination of the digestive tract (SDD) improves outcomes in ventilated patients in intensive care units (ICUs) and whether SDD is associated with the development of antibiotic resistance. Objective: To describe the study protocol and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) trial. Design, setting, participants and intervention: SuDDICU is an international, crossover, cluster randomised controlled trial of mechanically ventilated patients in ICUs using two 12-month trial periods. For each period, participating ICUs will implement SDD plus standard care or standard care alone. The SuDDICU drug intervention is an oral paste and gastric suspension of three antibiotics combined with a 4-day course of intravenous antibiotics. Observational ecological assessments will be conducted during five surveillance periods. The trial will be conducted in 19 ICUs in Australia and ten ICUs in Canada and the United Kingdom, and will recruit 15 000-17 000 patients. Recruitment commenced in Australia in 2017. Main outcome measures: The primary outcome is all-cause hospital mortality. Secondary outcomes include: duration of ventilation, ICU stay and hospital stay; incidence of new antibiotic-resistant organisms during the index ICU admission; changes in antibiotic-resistant organism rates; incidence of new Clostridioides difficile infections; and total use of antibiotics. Results and conclusions: SuDDICU will determine whether the use of SDD plus standard care is associated with a reduction in hospital mortality in ventilated ICU patients compared with standard care alone. It will also quantify the impact of the use of SDD on the development of antibiotic resistance. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12615000411549) and ClinicalTrials.gov (NCT02389036).

PubMed Disclaimer

Conflict of interest statement

The George Institute for Global Health holds all intellectual property rights related to the SuDDICU study drug, including component drug acquisition, manufacturing, packaging and distribution. None of the SuDDICU investigators have direct or indirect financial or commercial interests relating to the development of the SuDDICU study drug.

Figures

Figure 1
Figure 1
Trial design
See this image and copyright information in PMC

References

    1. Schimpff S.C. Infection prevention during profound granulocytopenia. New approaches to alimentary canal microbial suppression. Ann Intern Med. 1980;93:358–361. - PubMed
    1. de Smet A.M., Kluytmans J.A., Cooper B.S., et al. Decontamination of the digestive tract and oropharynx in ICU patients. N Engl J Med. 2009;360:20–31. - PubMed
    1. Stoutenbeek C.P., van Saene H.K., Miranda D.R., Zandstra D.F. The effect of selective decontamination of the digestive tract on colonisation and infection rate in multiple trauma patients. Intensive Care Med. 1984;10:185–192. - PubMed
    1. Wittekamp B.H.J., Oostdijk E.A.N., Cuthbertson B.H., et al. Selective decontamination of the digestive tract SDD in critically ill patients: a narrative review. Intensive Care Med. 2020;46:343–349. - PMC - PubMed
    1. de Smet A.M., Kluytmans J.A., Blok H.E., et al. Selective digestive tract decontamination and selective oropharyngeal decontamination and antibiotic resistance in patients in intensive-care units: an open-label, clustered group-randomised, crossover study. Lancet Infect Dis. 2011;11:372–380. - PubMed

Associated data