C. DifficileNCT05389904
Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile
A study testing Arm 1: Routine care and Arm 2: Preemptive C. difficile infection prevention bundle in people with C. Difficile, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C. Difficile
- What is being tested?
- Arm 1: Routine care and Arm 2: Preemptive C. difficile infection prevention bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab
Who cannot join
- Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pre-emptive Prevention Bundle 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.
- Conditions
- C. Difficile
- Being tested
- Arm 1: Routine care, Arm 2: Preemptive C. difficile infection prevention bundle
- Keywords
- Prevention, Hospital-acquired infection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Routine careOther
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 bundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients colonized with toxigenic C. difficile who do not receive the prevention bundle | Active comparator | Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care Receives: Other: Arm 1: Routine care |
| Patients colonized with toxigenic C. difficile who receive the prevention bundle | Active comparator | Patients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis. Receives: Other: Arm 2: Preemptive C. difficile infection prevention bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group
Incidence rate ratio of CDI in colonized patients who received the intervention bundle versus who did not receive the intervention bundle
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start25 Jul 2022
- Primary completion1 Jun 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C. DifficileStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Pilgrim Health Care Institute, Centers for Disease Control and Prevention, Massachusetts Host-Microbiome Center, Hatch Family Foundation
- Responsible party
- Principal investigator, Meghan A. Baker, M.D, Brigham and Women's Hospital
- Investigators
- Meghan A Baker, MD, SCD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389904
- Sponsor's protocol ID
- 2022P000819
- Status last verified
- Sep 2026
- First submitted
- 20 May 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile
- ClinicalTrials.gov ID
- NCT05389904
- Acronym / sponsor ID
- 2022P000819
- Conditions
- C. Difficile
- Keywords
- Prevention, Hospital-acquired infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Pilgrim Health Care Institute, Centers for Disease Control and Prevention, Massachusetts Host-Microbiome Center, Hatch Family Foundation
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patients colonized with toxigenic C. difficile who do not receive the prevention bundle | Active comparator | Other: Arm 1: Routine carePatients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive standard of care |
| Patients colonized with toxigenic C. difficile who receive the prevention bundle | Active comparator | Other: Arm 2: Preemptive C. difficile infection prevention bundlePatients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, who receive a preemptive prevention bundle for C. difficile including enhanced room cleaning, C. difficile precautions, pharmacist review and optimization of antibiotics and antacids, and consideration of vancomycin prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab
Key exclusion criteria (1 listed)
- Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: Routine carePatients colonized with toxigenic C. difficile, identified by testing routinely collected swabs for vancomycin-resistant enterococcus screening, will receive standard of care. | Other | Patients colonized with toxigenic C. difficile who do not receive the prevention bundle |
| Arm 2: Preemptive C. difficile infection prevention bundlePatients 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. | Other | Patients colonized with toxigenic C. difficile who receive the prevention bundle |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for C. Difficile
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
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Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Active, not recruitingPhase 2/3
LMN-201 for Prevention of C. Difficile Infection Recurrence
Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan A Baker, MD, SCD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Routine care and Arm 2: Preemptive C. difficile infection prevention bundle in people with C. Difficile, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.