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Preemptive Prevention Bundle for C. Difficile

N/A

Recruiting

Led By Meghan A Baker, MD, SCD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package.

Who is the study for?

This trial is for patients in ICU or oncology units who have been identified as carriers of C. difficile through a VRE swab test. It excludes those not carrying C. difficile and patients outside the ICU or oncology units.Check my eligibility

What is being tested?

The study compares routine care with a preemptive prevention bundle designed to stop asymptomatic carriers from developing active C. difficile infections and prevent them from transmitting it to others.See study design

What are the potential side effects?

Since the trial involves routine care and additional preventive measures, side effects may vary based on individual patient conditions but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am in the ICU or Oncology unit and tested positive for C. Difficile.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Other outcome measures

Oncology and ICU C. difficile infection rates

Trial Design

2Treatment groups

Active Control

Group I: Patients colonized with toxigenic C. difficile who do not receive the prevention bundleActive Control1 Intervention

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

Group II: Patients colonized with toxigenic C. difficile who receive the prevention bundleActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,612 Previous Clinical Trials

11,470,425 Total Patients Enrolled

Harvard Pilgrim Health Care InstituteUNKNOWN

1 Previous Clinical Trials

2,844 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,252 Total Patients Enrolled

Media Library

Preemptive C. difficile infection prevention bundle Clinical Trial Eligibility Overview. Trial Name: NCT05389904 — N/A

C. Difficile Research Study Groups: Patients colonized with toxigenic C. difficile who do not receive the prevention bundle, Patients colonized with toxigenic C. difficile who receive the prevention bundle

C. Difficile Clinical Trial 2023: Preemptive C. difficile infection prevention bundle Highlights & Side Effects. Trial Name: NCT05389904 — N/A

Preemptive C. difficile infection prevention bundle 2023 Treatment Timeline for Medical Study. Trial Name: NCT05389904 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the sample size of this clinical research?

"Affirmative. According to the clinicaltrials.gov website, this experiment is currently looking for participants and was initiated on July 25th 2022. Most recently, it has been updated on September 23rd 2022 and requires 150 patients from a single study site."

Answered by AI

Are there still available slots for people to join this clinical investigation?

"Affirmative. The clinical trial is actively seeking prospective participants, as evident on the information found on clinicaltrials.gov. This investigation was first made public on July 25th 2022 and has been updated most recently on September 23rd 2022; 150 people are required between 1 site to complete this project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Meghan A. Baker, M.D 2022. "Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05389904.