NCT05389904 Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile
| NCT ID | NCT05389904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | C. Difficile |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-07-25 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-07-25 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.
Eligibility Criteria
Inclusion Criteria: * Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab Exclusion Criteria: * Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units
Contact & Investigator
Meghan A Baker, MD, SCD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05389904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying C. Difficile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05389904 currently recruiting?
Yes, NCT05389904 is actively recruiting participants. Contact the research team at mbaker1@bwh.harvard.edu for enrollment information.
Where is the NCT05389904 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05389904 clinical trial?
NCT05389904 is sponsored by Brigham and Women's Hospital. The principal investigator is Meghan A Baker, MD, SCD at Brigham and Women's Hospital. The trial plans to enroll 300 participants.