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Vancomycin for Clostridium Difficile Infection

Phase 2

Waitlist Available

Led By Nasia Safdar, MD PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial is testing whether oral vancomycin can help prevent recurrent Clostridium difficile Infection (CDI) in patients who have had at least one CDI episode in the past 180 days and are taking antibiotics for a non-CDI condition.

Eligible Conditions

Clostridium Difficile (C. diff) Infection
Clostridium Difficile Infection
Clostridioides difficile Infection
Clostridioides difficile Diarrhea
Clostridioides difficile Colitis
Clostridium Difficile Colitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Recurrent Clostridium difficile infection (CDI)

Secondary outcome measures

Determine whether Clostridium difficile positivity on any stool sample is a predictor of CDI recurrence.

Gut microbiome composition

Vancomycin-resistant enterococcus (VRE) colonization in patients receiving vancomycin vs. placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VancomycinExperimental Treatment1 Intervention

125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days

Group II: PlaceboPlacebo Group1 Intervention

125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2005

Completed Phase 4

~7930

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Henry Ford HospitalOTHER

24 Previous Clinical Trials

6,292 Total Patients Enrolled

Mayo ClinicOTHER

3,206 Previous Clinical Trials

3,767,006 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,310 Total Patients Enrolled

Frequently Asked Questions

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

Are there a multitude of facilities executing this experiment in the state?

"Currently, 4 clinical sites are recruiting participants for this medical trial. Madison, Milwaukee, and Detroit are the main locations that prospective patients should consider; however there may be other local options available to them. To minimize travel needs while taking part in the study, it is prudent to select a location close by."

Answered by AI

Are there additional experiments with regards to Vancomycin?

"Currently, 6 Phase 3 trials are being conducted looking into the effectiveness of Vancomycin. These studies have spread to 315 locations internationally with a great concentration in Jupiter, Florida."

Answered by AI

Are there any opportunities for patients to participate in this trial at the present time?

"Affirmative, clinicaltrials.gov's data implies that this trial is currently attempting to recruit patients. This medical study was introduced on May 21st 2018 and updated most recently on November 8th 2022. 150 participants are necessary from 4 separate sites."

Answered by AI

What potential hazards should patients be aware of when taking Vancomycin?

"Vancomycin is currently being studied in a Phase 2 trial, so it received a rating of 2 on our safety scale. This signifies that while preliminary data exists to suggest its security, there are still no findings validating its efficacy."

Answered by AI

What ailments commonly respond to Vancomycin treatments?

"Vancomycin is an effective remedy for both staphylococcal infections, infection caused by staphylococci and enterocolitis induced by Staphylococcus aureus."

Answered by AI

To what extent is participation in this trial widespread?

"The trial requires 150 qualified participants and is being held at University of Wisconsin-Madison in Madison, WI as well as Medical College of Wisconsin in Milwaukee, MI."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection

2018. "Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03462459.