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Recruiting

NCT Number: NCT05389904

Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Meghan A Baker, MD, SCD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1: Routine Care

Other

Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care.

Arm 2: Preemptive C. difficile infection prevention bundle

Other

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.

Primary outcomes

  1. Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group

    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

Other outcomes

  1. Oncology and ICU C. difficile infection rates

    Time frame: 24 months

    Oncology and ICU C. difficile infection incidences before and after implementation of the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan A Baker, MD, SCD

CONTACT

[email protected]

617-732-8881

Sanjat Kanjilal, MD, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Harvard Pilgrim Health Care Institute
  • Hatch Family Foundation
  • Massachusetts Host-Microbiome Center

Registry information

Official study title

A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 25, 2022
Registry last updated
Mar 4, 2026

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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