The SuDDICU Study of Antibiotic Prophylaxis in Critical Illness
A crossover, cluster randomised controlled trial of selective decontamination of the digestive tract in intensive care patients (SuDDICU)
The George Institute for Global Health
15,000 participants
May 15, 2017
Interventional
Conditions
Summary
Selective Decontamination of the Digestive Tract (SDD) is a treatment designed to reduce the risk of infection and improve survival for critically ill patients. SDD is the application of antibiotics and antifungal drugs to the throat and their instillation into the stomach, combined with a short course of intravenous antibiotics. Although many trials suggest that SDD works, the research results have not been convincing enough to lead to the widespread uptake of SDD around the world. Additionally clinicians are concerned that SDD will increase antibiotic resistance amongst endemic bacteria. As a result, SDD is not currently widely practiced. This trial aims to resolve this uncertainty. We will be conducting the definitive randomised study examining the effect of implementing SDD. For 24 months, ICUs in Australia will be randomly assigned to either deliver SDD in the first 12-month period and be a control ICU in the second 12-month period, or to be a control ICU first and deliver SDD in the second period. 8000 critically ill mechanically ventilated patients will be enrolled. Mortality rates will be compared between the SDD and control groups antibiotic resistance rates will be evaluated in samples from all patients prior to, during and after the trial to determine the effect of SDD on the microbial ecology. The SuDDICU trial will provide definitive answer to a fundamental question in intensive care medicine - does SDD reduce critically ill patients’ risk of dying without increasing antibiotic resistance rates? If SDD is found to be effective without increasing antibiotic resistance, the study will have a global impact, leading to improved survival and reduced infection rates in critically ill patients. The results of this study will change practice and be of immense value to clinicians, policy makers and regulators.
Eligibility
Inclusion Criteria5
- Site inclusion for cluster study:
- A general ICU or complex of ICUs (medical, surgical, mixed) capable of treating mechanically ventilated critically ill patients.
- 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.
Exclusion Criteria9
- Unwilling or unable to follow trial protocols.
- Unable to capture the minimum data set required for the study.
- Isolated specialty ICUs (non 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
- 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
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Interventions
SDD intervention group; All patients in the intervention group will receive all 3 treatments. all treatment will occur simultaneously. The topical and enteral intervention will continue until tracheal extubation, removal of the enteral feeding tube, 24-hours unsupported spontaneous ventilation via tracheostomy, or ICU discharge, whichever comes first, for a maximum of 90 days. The IV Antibiotic intervention will be continued for 4 days. The study treatments will be administered by qualified ICU nurse. The intervention will entail: 1. SDD paste: 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. SDD suspension: The six-hourly administration of 10 mls suspension containing 100 mg colistin/ polymixin, 80 mg tobramycin and 2 x 106 IU nystatin, to the gastrointestinal tract via the gastric / jejunal tube. 3. A four-day course of an intravenous 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 intravenous antibiotic to treat infection will not receive this additional intravenous antibiotic, but will continue the prescribed antibiotic for the usual duration of therapy
Locations(18)
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ACTRN12615000411549