Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Location contact
Meghan A Baker, MD, SCD
CONTACT
NCT Number: NCT05389904
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Meghan A Baker, MD, SCD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.
Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive a preemptive prevention bundle for C. difficile. The prevention bundle will include enhanced room cleaning, C. difficile precautions (staff entering room must wear gown and gloves and wash hands with soap and water upon exiting the room), pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis.
Time frame: 24 months
Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle
Time frame: 24 months
Oncology and ICU C. difficile infection incidences before and after implementation of the intervention
Contact information is provided by the study sponsor or research team.
Meghan A Baker, MD, SCD
CONTACT
Sanjat Kanjilal, MD, MPH
CONTACT
Brigham and Women's Hospital
Other
A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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