Critical IllnessPhase 3SuDDICUNCT02389036
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients
A Phase 3 study testing SDD Oral Paste, SDD Gastric Suspension and Intravenous Antibiotic in people with Critical Illness and Sepsis, run by The George Institute at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Septic Shock
- What is being tested?
- SDD Oral Paste, SDD Gastric Suspension and Intravenous Antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,010 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 May 2017to 26 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
- 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 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-
Show all 10Show fewer
- Unwilling or unable to follow trial protocols.
- Unable to capture the minimum data set required for the study.
- 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
- Specialty paediatric ICUs
Who cannot join
- Patient exclusion criteria
- Patients enrolled in a trial that would interact with the intervention
- Patients with a known allergy, sensitivity or interaction to trial topical intervention drugs
- Patients who are known or suspected to be pregnant
- Patients who are moribund and not expected to survive the next 12 hours
- Patients less than 16 years of age will not be enrolled in the UK
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Australia1 site
The George Institute for Global Health
Sydney, New South Wales, 2000
About this study
Official title: A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
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.
Read the detailed description
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 29 ICUs and will have 80% power to detect an absolute reduction in hospital mortality of 3-5% from a baseline mortality of 29%, depending on the precise number of clusters.
- Being tested
- SDD Oral Paste, SDD Gastric Suspension, Intravenous Antibiotic
- Medical subject headings
- Critical Illness, Sepsis, Shock, Septic, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDD Oral PasteDrug
Also called Colistin, Tobramycin and Nystatin
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
SDD Gastric SuspensionDrug
Also called Colistin, Tobramycin and Nystatin
- 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
Intravenous AntibioticDrug
Also called Ceftriaxone, Cefotaxime or Ciprofloxacin
A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Control group- standard care | No intervention | 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. |
| SDD intervention group | Experimental | 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. Receives: Drug: SDD Oral Paste; Drug: SDD Gastric Suspension; Drug: Intravenous Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
all-cause mortality at time of hospital discharge
Measured: Hospital discharge [up to Day 90 after randomization]
Secondary outcomes (9)
Total antibiotic usage
Total antibiotic usage (as daily defined doses) during ICU admission in all ICU admissions.
Measured: during ICU admission
The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites
The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites during ICU admission in all ICU admissions.
Measured: during ICU admission
The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens
The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens during ICU admission in all ICU admissions
Measured: during ICU admission
The incidence of C. difficile infections
The incidence of C. difficile infections during ICU admission in all ICU admissions
Measured: during ICU admission
Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups
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
Measured: Through out all study periods
Duration of mechanical ventilation
Duration that the patient is mechanically ventilated in the ICU
Measured: Time of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization]
ICU length of stay
The length of time a patient stays in the ICU
Measured: From the time of enrolment to ICU discharge, [up to Day 90 after randomization]
Hospital length of stay
The total hospital length of stay for patient
Measured: From time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization]
ICU Mortality
mortality at time of ICU discharge
Measured: ICU discharge [up to Day 90 after randomization]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start1 May 2017
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster, crossover, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- John Myburgh, MBBCh PhD, Study chair, The George InstituteBrian Cuthbertson, MD FRCA, Study chair, Sunnybrook Health Sciences CentreAnthony Gordon, MD FRCA, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389036
- Sponsor's protocol ID
- GI-CCT070115
- Acronym
- SuDDICU
- Status last verified
- Aug 2023
- First submitted
- 2 Mar 2015
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Cuthbertson BH, Campbell MK, MacLennan G, Duncan EM, Marshall AP, Wells EC, Prior ME, Todd L, Rose L, Seppelt IM, Bellingan G, Francis JJ. Clinical stakeholders' opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study. Crit Care. 2013 Nov 8;17(6):R266. doi: 10.1186/cc13096.
PubMed 24207137Daneman N, Sarwar S, Fowler RA, Cuthbertson BH; SuDDICU Canadian Study Group. Effect of selective decontamination on antimicrobial resistance in intensive care units: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Apr;13(4):328-41. doi: 10.1016/S1473-3099(12)70322-5. Epub 2013 Jan 25.
PubMed 23352693Cuthbertson BH, Francis J, Campbell MK, MacIntyre L, Seppelt I, Grimshaw J; SuDDICU study groups. A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (the SuDDICU study). Trials. 2010 Dec 3;11:117. doi: 10.1186/1745-6215-11-117.
PubMed 21129208Dainty KN, Seaton MB, Amog K, Murthy S, Pinto R, Cuthbertson BH, Rose L. A process evaluation of a randomized clinical trial of selective decontamination of the digestive tract in ventilated adults admitted to intensive care: the SuDDICU PE study. Trials. 2026 Aug 14;27(1):546. doi: 10.1186/s13063-026-09935-6.
PubMed 42642777SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group; Cuthbertson BH, Billot L, Campbell MK, Daneman N, Davis JS, Delaney A, Devaux A, Ferguson ND, Finfer SR, Fowler R, Gordon AC, Hammond NE, Klein G, Li Q, Marshall J, Micallef S, Murthy S, Mysore J, Naik C, Patel C, Pinto R, Rose L, Seppelt IM, Venkatesh B, Young PJ, Myburgh JA; The SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group. Selective Decontamination of the Digestive Tract during Ventilation in the ICU. N Engl J Med. 2026 Apr 16;394(15):1491-1502. doi: 10.1056/NEJMoa2506398. Epub 2025 Oct 29.
PubMed 41159880Billot L, Cuthbertson B, Gordon A, Al-Beidh F, Correa M, Davis J, Finfer S, Glass P, Goodman F, Hammond N, Iredell J, Miller J, Murthy S, Rose L, Seppelt I, Taylor C, Young P, Myburgh J; SuDDICU Investigators. Protocol summary and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) crossover, cluster randomised controlled trial. Crit Care Resusc. 2023 Oct 18;23(2):183-193. doi: 10.51893/2021.2.oa5. eCollection 2021 Jun.
PubMed 38045525Young PJ, Devaux A, Li Q, Billot L, Davis JS, Delaney A, Finfer SR, Hammond NE, Micallef S, Seppelt IM, Venkatesh B, Myburgh JA; SuDDICU Australia Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Selective digestive tract decontamination in critically ill adults with acute brain injuries: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Jan;50(1):56-67. doi: 10.1007/s00134-023-07261-y. Epub 2023 Nov 20.
PubMed 37982826SuDDICU Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group; Myburgh JA, Seppelt IM, Goodman F, Billot L, Correa M, Davis JS, Gordon AC, Hammond NE, Iredell J, Li Q, Micallef S, Miller J, Mysore J, Taylor C, Young PJ, Cuthbertson BH, Finfer SR. Effect of Selective Decontamination of the Digestive Tract on Hospital Mortality in Critically Ill Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2022 Nov 15;328(19):1911-1921. doi: 10.1001/jama.2022.17927.
PubMed 36286097
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover, Cluster Randomised Controlled Trial of Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU)
- ClinicalTrials.gov ID
- NCT02389036
- Acronym / sponsor ID
- SuDDICU / GI-CCT070115
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,010 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Imperial College London, Sunnybrook Health Sciences Centre
- Study start
- 1 May 2017 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 29 ICUs and will have 80% power to detect an absolute reduction in hospital mortality of 3-5% from a baseline mortality of 29%, depending on the precise number of clusters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster, crossover, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group- standard care | No intervention | –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. |
| SDD intervention group | Experimental | Drug: SDD Oral Paste, Drug: SDD Gastric Suspension, Drug: Intravenous AntibioticThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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
- 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 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.
Key exclusion criteria (6 listed)
- Patient exclusion criteria
- Patients enrolled in a trial that would interact with the intervention
- Patients with a known allergy, sensitivity or interaction to trial topical intervention drugs
- Patients who are known or suspected to be pregnant
- Patients who are moribund and not expected to survive the next 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDD Oral PasteAlso: Colistin, Tobramycin and NystatinA 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 intervention group |
| SDD Gastric SuspensionAlso: Colistin, Tobramycin and Nystatin2. 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 | SDD intervention group |
| Intravenous AntibioticAlso: Ceftriaxone, Cefotaxime or CiprofloxacinA four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic | Drug | SDD intervention group |
Primary outcome
Hospital Mortality
Time frame: Hospital discharge [up to Day 90 after randomization]
all-cause mortality at time of hospital discharge
9 secondary outcomes
Total antibiotic usage
Time frame: during ICU admission
The incidence of antibiotic resistant organisms in cultures from blood or other sterile sites
Time frame: during ICU admission
The incidence of antibiotic-resistant organism in non-sterile clinical and surveillance specimens
Time frame: during ICU admission
The incidence of C. difficile infections
Time frame: during ICU admission
Changes in antibiotic resistance rates between study epochs (pre-trial, interperiod gap and post-trial) within groups
Time frame: Through out all study periods
Duration of mechanical ventilation
Time frame: Time of enrolment to ICU discharge within index hospital admission,[up to Day 90 after randomization]
ICU length of stay
Time frame: From the time of enrolment to ICU discharge, [up to Day 90 after randomization]
Hospital length of stay
Time frame: From time of enrolment to hospital discharge within the index hospital admission, [up to Day 90 after randomization]
ICU Mortality
Time frame: ICU discharge [up to Day 90 after randomization]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 24207137Cuthbertson BH, Campbell MK, MacLennan G, Duncan EM, Marshall AP, Wells EC, Prior ME, Todd L, Rose L, Seppelt IM, Bellingan G, Francis JJ. Clinical stakeholders' opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study. Crit Care. 2013 Nov 8;17(6):R266. doi: 10.1186/cc13096.
- Results publication: PubMed 23352693Daneman N, Sarwar S, Fowler RA, Cuthbertson BH; SuDDICU Canadian Study Group. Effect of selective decontamination on antimicrobial resistance in intensive care units: a systematic review and meta-analysis. Lancet Infect Dis. 2013 Apr;13(4):328-41. doi: 10.1016/S1473-3099(12)70322-5. Epub 2013 Jan 25.
- Results publication: PubMed 21129208Cuthbertson BH, Francis J, Campbell MK, MacIntyre L, Seppelt I, Grimshaw J; SuDDICU study groups. A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (the SuDDICU study). Trials. 2010 Dec 3;11:117. doi: 10.1186/1745-6215-11-117.
- Derived from this study: PubMed 42642777Dainty KN, Seaton MB, Amog K, Murthy S, Pinto R, Cuthbertson BH, Rose L. A process evaluation of a randomized clinical trial of selective decontamination of the digestive tract in ventilated adults admitted to intensive care: the SuDDICU PE study. Trials. 2026 Aug 14;27(1):546. doi: 10.1186/s13063-026-09935-6.
- Derived from this study: PubMed 41159880SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group; Cuthbertson BH, Billot L, Campbell MK, Daneman N, Davis JS, Delaney A, Devaux A, Ferguson ND, Finfer SR, Fowler R, Gordon AC, Hammond NE, Klein G, Li Q, Marshall J, Micallef S, Murthy S, Mysore J, Naik C, Patel C, Pinto R, Rose L, Seppelt IM, Venkatesh B, Young PJ, Myburgh JA; The SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group. Selective Decontamination of the Digestive Tract during Ventilation in the ICU. N Engl J Med. 2026 Apr 16;394(15):1491-1502. doi: 10.1056/NEJMoa2506398. Epub 2025 Oct 29.
- Derived from this study: PubMed 38045525Billot L, Cuthbertson B, Gordon A, Al-Beidh F, Correa M, Davis J, Finfer S, Glass P, Goodman F, Hammond N, Iredell J, Miller J, Murthy S, Rose L, Seppelt I, Taylor C, Young P, Myburgh J; SuDDICU Investigators. Protocol summary and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) crossover, cluster randomised controlled trial. Crit Care Resusc. 2023 Oct 18;23(2):183-193. doi: 10.51893/2021.2.oa5. eCollection 2021 Jun.
- Derived from this study: PubMed 37982826Young PJ, Devaux A, Li Q, Billot L, Davis JS, Delaney A, Finfer SR, Hammond NE, Micallef S, Seppelt IM, Venkatesh B, Myburgh JA; SuDDICU Australia Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Selective digestive tract decontamination in critically ill adults with acute brain injuries: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Jan;50(1):56-67. doi: 10.1007/s00134-023-07261-y. Epub 2023 Nov 20.
- Derived from this study: PubMed 36286097SuDDICU Investigators for the Australian and New Zealand Intensive Care Society Clinical Trials Group; Myburgh JA, Seppelt IM, Goodman F, Billot L, Correa M, Davis JS, Gordon AC, Hammond NE, Iredell J, Li Q, Micallef S, Miller J, Mysore J, Taylor C, Young PJ, Cuthbertson BH, Finfer SR. Effect of Selective Decontamination of the Digestive Tract on Hospital Mortality in Critically Ill Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2022 Nov 15;328(19):1911-1921. doi: 10.1001/jama.2022.17927.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Myburgh, MBBCh PhD study chair
The George Institute
Brian Cuthbertson, MD FRCA study chair
Sunnybrook Health Sciences Centre
Anthony Gordon, MD FRCA study chair
Imperial College London
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SDD Oral Paste, SDD Gastric Suspension and Intravenous Antibiotic in people with Critical Illness and Sepsis, run by The George Institute at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: Hospital discharge [up to Day 90 after randomization]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389036, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.