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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02389036
Registration number
NCT02389036
Ethics application status
Date submitted
2/03/2015
Date registered
17/03/2015
Date last updated
14/08/2023
Titles & IDs
Public title
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
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Scientific title
A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
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Secondary ID [1]
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GI-CCT070115
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Universal Trial Number (UTN)
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Trial acronym
SuDDICU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Sepsis
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Septic Shock
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Ventilator Associated Pneumonia
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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:
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
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
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hospital Mortality
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Assessment method [1]
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all-cause mortality at time of hospital discharge
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Timepoint [1]
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Hospital discharge [up to Day 90 after randomization]
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Secondary outcome [1]
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Total antibiotic usage
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Assessment method [1]
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Total antibiotic usage (as daily defined doses) during ICU admission in all ICU admissions.
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Timepoint [1]
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during ICU admission
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Secondary outcome [2]
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The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites
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Assessment method [2]
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The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites during ICU admission in all ICU admissions.
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Timepoint [2]
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during ICU admission
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Secondary outcome [3]
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The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens
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Assessment method [3]
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The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens during ICU admission in all ICU admissions
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Timepoint [3]
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during ICU admission
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Secondary outcome [4]
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The incidence of C. difficile infections
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Assessment method [4]
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The incidence of C. difficile infections during ICU admission in all ICU admissions
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Timepoint [4]
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during ICU admission
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Secondary outcome [5]
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Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups
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Assessment method [5]
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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
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Timepoint [5]
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Through out all study periods
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Secondary outcome [6]
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Duration of mechanical ventilation
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Assessment method [6]
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Duration that the patient is mechanically ventilated in the ICU
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Timepoint [6]
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Time of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization]
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Secondary outcome [7]
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ICU length of stay
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Assessment method [7]
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The length of time a patient stays in the ICU
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Timepoint [7]
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From the time of enrolment to ICU discharge, [up to Day 90 after randomization]
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Secondary outcome [8]
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Hospital length of stay
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Assessment method [8]
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The total hospital length of stay for patient
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Timepoint [8]
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From time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization]
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Secondary outcome [9]
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ICU Mortality
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Assessment method [9]
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mortality at time of ICU discharge
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Timepoint [9]
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ICU discharge [up to Day 90 after randomization]
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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
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/04/2023
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Sample size
Target
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Accrual to date
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Final
20010
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute for Global Health - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Toronto
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Country [2]
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United Kingdom
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State/province [2]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Imperial College London
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Sunnybrook Health Sciences Centre
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02389036
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Myburgh, MBBCh PhD
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02389036
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