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Trial · NCT02389036

Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients

NCT02389036, Phase 3, Completed, The George Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients. Trials, record NCT02389036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02389036

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
NCT number
NCT02389036
Status
Completed
Phases
Phase 3
Enrollment
20,010 participants, actual
Lead sponsor
The George Institute
Conditions
Critical Illness, Sepsis, Septic Shock, Ventilator Associated Pneumonia
Interventions
SDD Oral Paste, SDD Gastric Suspension, Intravenous Antibiotic
First posted
2015-03-17
Last updated
2023-08-14

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryHospital MortalityHospital discharge [up to Day 90 after randomization]all-cause mortality at time of hospital discharge
SecondaryTotal antibiotic usageduring ICU admissionTotal antibiotic usage (as daily defined doses) during ICU admission in all ICU admissions.
SecondaryThe incidence of antibiotic resistant organisms in cultures from blood or other sterile sitesduring ICU admissionThe incidence of antibiotic resistant organisms in cultures from blood or other sterile sites during ICU admission in all ICU admissions.
SecondaryThe incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimensduring ICU admissionThe incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens during ICU admission in all ICU admissions
SecondaryThe incidence of C. difficile infectionsduring ICU admissionThe incidence of C. difficile infections during ICU admission in all ICU admissions
SecondaryChanges in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groupsThrough out all study periods
Changes in ARO rates between time epochs (pre-trial, trial, inter-period gap and post-trial) within groups. With control group data to give the secular trend in ARO with time and SDD group data studying the effects of SDD withdrawal from practice in the year after SDD delivery
SecondaryDuration of mechanical ventilationTime of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization]Duration that the patient is mechanically ventilated in the ICU
SecondaryICU length of stayFrom the time of enrolment to ICU discharge, [up to Day 90 after randomization]The length of time a patient stays in the ICU
SecondaryHospital length of stayFrom time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization]The total hospital length of stay for patient
SecondaryICU MortalityICU discharge [up to Day 90 after randomization]mortality at time of ICU discharge

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
21129208RESULTPubMed
23352693RESULTPubMed
24207137RESULTPubMed
36286097DERIVEDPubMed
37982826DERIVEDPubMed
38045525DERIVEDPubMed
41159880DERIVEDPubMed
42642777DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02389036

GET https://conductscience.org/api/trials/v1/NCT02389036/registered