Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

20,010

Participants

Timeline

Start Date

May 1, 2017

Primary Completion Date

April 26, 2023

Study Completion Date

April 26, 2023

Conditions
Critical IllnessSepsisSeptic ShockVentilator Associated Pneumonia
Interventions
DRUG

SDD Oral Paste

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

DRUG

SDD Gastric Suspension

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

DRUG

Intravenous Antibiotic

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

Trial Locations (3)

2000

The George Institute for Global Health, Sydney

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

W21PG

Imperial College London, London

All Listed Sponsors
collaborator

Imperial College London

OTHER

collaborator

Sunnybrook Health Sciences Centre

OTHER

lead

The George Institute

OTHER

NCT02389036 - Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients | Biotech Hunter | Biotech Hunter