Data

ROCIT

Curtin University

Dataset description

The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five CUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained Lactobacillus plantarum 299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60.
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Source Study

Purpose

Treatment

Phase

Phase 1 / Phase 2

Funding

Charities/Societies/Foundations,Australian Red Cross Lifebood (ARCL)

Scientific enquiries

Dr Fionnuala Murray

Brief Summary

In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including t ....
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Key Inclusion Criteria

i) Age 18 years or older. ii) Inpatient in ICU for minimum of 96 hours who have an ongoing requirement for ICU at the time of enrolment iii) Received a minimum of 24 hours of broad-spectrum antimicrobials in the week preceding enrolment and not anticipated to require ongoing broad-spectrum antibiotics within 24 hours prior to FMT iv) Evidence of persistent organ dysfunction as defined by at least one of i) ongoing ventilatory support [high flow nasal prong oxygen, non-invasive ventilation, mecha ....
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Key Exclusion Criteria

i)Patients with established concurrent indications for FMT including C. difficile infection and inflammatory bowel disease (IBD). ii)Subjects with compromised immune system, including: (a) Absolute neutrophil count (ANC) of less than 0.5 x 109 cells / L within 7 days of enrolment or sustained AN less than 1 x 109 cell / L., (b) Subjects on active chemotherapy or monoclonal therapy targeting B or T cells, glucocorticoids > 10mg prednisolone daily or equivalent for greater than or equal to 2 weeks ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    40

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Persistent Critical Illness

Condition code    Cardiovascular , Infection , Inflammatory and Immune System , Oral and Gastrointestinal , Renal and Urogenital , Respiratory

Intervention

Intervention code Treatment: Other

Escalating doses of Australian Red Cross Lifeblood faecal microbiota transplant (FMT) product will be administered via nasogastric tube at pre-determined escalation infusion rates to participants who meet the eligibility criteria and provide informed consent. Initial dose will be 50g of FMT at a rate of 25ml/hr to initial 3 participants. The dose will then be escalated to 100g at 25ml/hr to the next 3 participants pending tolerability of the initial dose. The infusion rate will subsequently be e ....
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Comparison

Control group Uncontrolled

No control group

Outcomes

Outcome: i) Safety of FMT via NG administration in ICU patients with evidence of PerCI, as assessed by the incidence of grade 3-5 FMT-related adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. FMT will be considered unsafe in critically ill patients when there are definitely FMT-related SAE in >1 participant. - data will be collected from electronic medical records
Timepoint: Baseline, Day 5, Day 7, Day 30 post FMT admin ....

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Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

No

What data in particular will be shared?

When will data be available?

Available to whom?

Available for what types of analyses?

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au