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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02389036




Registration number
NCT02389036
Ethics application status
Date submitted
2/03/2015
Date registered
17/03/2015

Titles & IDs
Public title
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
Scientific title
A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
Secondary ID [1] 0 0
GI-CCT070115
Universal Trial Number (UTN)
Trial acronym
SuDDICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Sepsis 0 0
Septic Shock 0 0
Ventilator Associated Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SDD Oral Paste
Treatment: Drugs - SDD Gastric Suspension
Treatment: Drugs - Intravenous Antibiotic

No intervention: Control group- standard care - Standard care- In Australia there are no national guidelines so local policy is determined by each ICU. We are recommending (but not mandating) that control and SDD group management be in line with these national guidelines. We will recommend control and SDD group management is in line with current national standards of practice that may or may not include a VAP bundle. We will monitor record data regarding the nature and delivery of the control and SDD group co-interventions.

Experimental: SDD intervention group - The intervention will entail:

1. 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
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
3. A four-day course of an IV antibiotic. Patients not already receiving a therapeutic antibiotic will be prescribed cefotaxime 1g six-hourly or ceftriaxone 1g daily, with dose adjusted as appropriate for organ dysfunction. Ciprofloxacin (400mg 12-hourly) may be used as an alternative if there is a contraindication to cephalosporins (e.g. allergy). Patients already receiving an alternative IV antibiotic to treat infection will not receive this additional IV antibiotic, but will continue the prescribed antibiotic for the usual duration of therapy.


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: Intravenous Antibiotic
A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital Mortality
Timepoint [1] 0 0
Hospital discharge [up to Day 90 after randomization]
Secondary outcome [1] 0 0
Total antibiotic usage
Timepoint [1] 0 0
during ICU admission
Secondary outcome [2] 0 0
The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites
Timepoint [2] 0 0
during ICU admission
Secondary outcome [3] 0 0
The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens
Timepoint [3] 0 0
during ICU admission
Secondary outcome [4] 0 0
The incidence of C. difficile infections
Timepoint [4] 0 0
during ICU admission
Secondary outcome [5] 0 0
Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups
Timepoint [5] 0 0
Through out all study periods
Secondary outcome [6] 0 0
Duration of mechanical ventilation
Timepoint [6] 0 0
Time of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization]
Secondary outcome [7] 0 0
ICU length of stay
Timepoint [7] 0 0
From the time of enrolment to ICU discharge, [up to Day 90 after randomization]
Secondary outcome [8] 0 0
Hospital length of stay
Timepoint [8] 0 0
From time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization]
Secondary outcome [9] 0 0
ICU Mortality
Timepoint [9] 0 0
ICU discharge [up to Day 90 after randomization]

Eligibility
Key inclusion criteria
Site inclusion for cluster study- A general ICU or complex of ICUs (medical, surgical, mixed) capable of treating mechanically ventilated critically ill adult patients.

Patient inclusion criteria

1. All patients who are mechanically ventilated via an endotracheal tube on admission to ICU and who are predicted to remain ventilated beyond the end of the calendar day after the day of ICU admission, or
2. All patients who become mechanically ventilated via an endotracheal tube during their ICU stay and who are predicted to remain ventilated beyond the end of the calendar day after the day they are first ventilated, or
3. All patients not already recruited who are receiving mechanical ventilation via an endotracheal tube and are expected to receive ongoing ventilation for a further 48 hours or more despite an earlier prediction that ventilation would be discontinued earlier.

Site exclusion criteria for cluster study-

1. Unwilling or unable to follow trial protocols.
2. Unable to capture the minimum data set required for the study.
3. Isolated specialty ICUs not co-located with a general ICU, such as solely cardiac, neurological/neurosurgical and burns ICUs, but such specialty patients cared for in general ICUs will be included
4. Specialty paediatric ICUs
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient exclusion criteria

1. Patients enrolled in a trial that would interact with the intervention
2. Patients with a known allergy, sensitivity or interaction to trial topical intervention drugs
3. Patients who are known or suspected to be pregnant
4. Patients who are moribund and not expected to survive the next 12 hours
5. Patients less than 16 years of age will not be enrolled in the UK

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2023
Sample size
Target
Accrual to date
Final
20010
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Toronto
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Imperial College London
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Health Sciences Centre
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Myburgh, MBBCh PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The protocol and statistical analysis plan were made public in 2020. The participant level dataset will not be publicly available immediately but will be available to collaborative researchers after consultation and negotiation with the SuDDICU Investigators.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
The SuDDICU Protocol V4.0 and SAP V1.1 are available on the open science framework in pre print.
Available to whom?
Public access, no access criteria to view the SuDDICU Protocol V4.0 and SAP V1.1
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://osf.io/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02389036