Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02389036|
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : June 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Sepsis Septic Shock Ventilator Associated Pneumonia||Drug: SDD Oral Paste Drug: SDD Gastric Suspension Drug: Intravenous Antibiotic||Phase 3|
Design- international, multicentre, crossover, cluster randomised controlled trial (x-cRCT) of eligible patients in participating ICUs using two 12-month interventional trial periods separated by a 3-month inter-period gap.
An observational ecological assessment will be conducted in all ICU patients during one week of each month during the 3-month surveillance period before the first intervention period; in all trial eligible patients during the two 12-month intervention periods; in all ICU patients during one week of each month of the final 3-months of the two intervention periods; in all ICU patients during one week of each month during the 3-month inter-period and post-trial periods.
Participants- General ICUs that admit mechanically ventilated patients will be randomised in the first 12-month period to either implement the SDD protocol in addition to standard care or to continue standard care without SDD, and then to cross over to the other arm during the second 12-month period.
Eligible patients are defined as:
- All patients who are mechanically ventilated via an endotracheal tube on admission to the ICU and who are predicted to remain ventilated beyond the end of the calendar day after the day of ICU admission, or
- 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
- All patients who not already recruited but 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.
All patients eligible for the intervention will receive the following in addition to the usual infection control measures:
- 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
- A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 106 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.
Statistical considerations and sample size- SuDDICU will recruit 10 000 to 15 000 patients from 40 to 50 ICUs and will have 80% power to detect an absolute reduction in hospital mortality of 3% from a baseline mortality of 29%, depending on the precise number of clusters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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:
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
Other Name: Colistin, Tobramycin and Nystatin
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
Other Name: Colistin, Tobramycin and Nystatin
Drug: Intravenous Antibiotic
A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic
Other Name: Ceftriaxone, Cefotaxime or Ciprofloxacin
- Hospital Mortality [ Time Frame: Hospital discharge [up to 6 months after randomization ]all-cause mortality at time of hospital discharge
- Total antibiotic usage [ Time Frame: during ICU admission ]Total antibiotic usage (as daily defined doses) during ICU admission in all ICU admissions.
- The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites [ Time Frame: during ICU admission ]The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites during ICU admission in all ICU admissions.
- The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens [ Time Frame: during ICU admission ]The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens during ICU admission in all ICU admissions
- The incidence of C. difficile infections [ Time Frame: during ICU admission ]The incidence of C. difficile infections during ICU admission in all ICU admissions
- Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups [ Time Frame: Through 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
- Duration of mechanical ventilation [ Time Frame: Time of enrolment to ICU discharge within index hospital admission, assessed up to 12 months ]Duration that the patient is mechanically ventilated in the ICU
- ICU length of stay [ Time Frame: From the time of enrolment to ICU discharge, assessed up to 12 months ]The length of time a patient stays in the ICU
- Hospital length of stay [ Time Frame: From time of enrolment to hospital discharge within the index hospital admission, assessed up to 12 months ]The total hospital length of stay for patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389036
|Contact: John Myburgh, MBBCh PhD||+61 2 8052 firstname.lastname@example.org|
|Contact: Ian Seppelt, MBBS PhD||+61 412 595 647||Iseppelt@georgeinstitute.org.au|
|Australia, New South Wales|
|The George Institute for Global Health||Recruiting|
|Sydney, New South Wales, Australia, 2000|
|Contact: John Myburgh, | MBBCh PhD 61 2 8052 4348 email@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Canada, M4N 3M5|
|Contact: Brian Cuthbertson firstname.lastname@example.org|
|Study Chair:||John Myburgh, MBBCh PhD||The George Institute|
|Study Chair:||Brian Cuthbertson, MD FRCA||Sunnybrook Health Sciences Centre|