Patients colonized with toxigenic C. difficile who do not receive the prevention bundle for C. Difficile Colonization

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
C. Difficile Colonization+1 More
Arm 1: Routine care - Other
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions

  • C. Difficile Colonization
  • Clostridium Difficile (C. Difficile)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for C. Difficile Colonization

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 months

24 months
Oncology and ICU C. difficile infection rates
Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group

Trial Safety

Safety Progress

1 of 3

Other trials for C. Difficile Colonization

Trial Design

2 Treatment Groups

Patients colonized with toxigenic C. difficile who do not receive the prevention...
1 of 2
Patients colonized with toxigenic C. difficile who receive the preemptive preven...
1 of 2
Active Control

150 Total Participants · 2 Treatment Groups

Primary Treatment: Patients colonized with toxigenic C. difficile who do not receive the prevention bundle · No Placebo Group · N/A

Patients colonized with toxigenic C. difficile who do not receive the prevention bundle
Other
ActiveComparator Group · 1 Intervention: Arm 1: Routine care · Intervention Types: Other
Patients colonized with toxigenic C. difficile who receive the preemptive prevention bundle
Other
ActiveComparator Group · 1 Intervention: Arm 2: Preemptive C. difficile infection prevention bundle · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Trial Background

Meghan A. Baker M.D, Assistant Epidemiologist
Principal Investigator
Brigham and Women's Hospital
Closest Location: Brigham and Women's Hospital · Boston, MA
Photo of Boston  1Photo of Boston  2Photo of Boston  3
2008First Recorded Clinical Trial
1 TrialsResearching C. Difficile Colonization
1041 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.