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

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462459
• Other study ID #: 2017-0927
• Secondary ID: 1R01HS025713-01A
• Status: Completed
• Phase: Phase 2
• Start date: May 21, 2018
• Est. completion date: July 6, 2023

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

Description:

Many patients who have a CDI experience recurrent or relapsing symptoms. The investigators are studying whether vancomycin in low doses will help prevent further CDI episodes and how this therapy impacts patients' gastrointestinal microbiome and composition. Patients with a history of past CDI who are receiving antibiotics for a non-CDI condition will be invited to participate. Approximately half of the participants will receive a low-dose capsule of vancomycin and half will receive a placebo. Participants will continue taking the vancomycin/placebo for 5 days after their prescribed antibiotics end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing to provide informed consent.
• Willing to comply with all study procedures and be available for the duration of the study.
• Documented diagnosis of at least one CDI within the last 180 days with treatment completed.
• Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks.
• Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion.
• Have received no more than 72 hours of non-CDI antibiotics.

Exclusion Criteria:

• History of hypersensitivity or allergy to oral vancomycin.
• Current use of oral vancomycin
• Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication
• Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g. Salmonella sp.), toxic megacolon and/or known small bowel ileus.
• Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
• Major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy).
• Any history of total colectomy or bariatric surgery.
• Unable or unwilling to fulfill study requirements.
• Expected life expectancy < 6 months.
• Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization.
• Women who are pregnant or breast-feeding.
• Any patient deemed not suitable for study participation at the discretion of the study investigator.
• Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.

Related Conditions & MeSH terms

• C. Diff Colitis
• C.Difficile Colitis
• C.Difficile Diarrhea
• CDI
• Clostridium Difficile Infection
• Clostridium Infections
• Colitis
• Communicable Diseases
• Diarrhea
• Infections
• Recurrence
• Recurrent Clostridium Difficile Infection

Intervention

Drug:
• Vancomycin
Vancomycin capsule, 125 mg
• Placebo
Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ), Henry Ford Hospital, Mayo Clinic, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Clostridium difficile infection (CDI)	Determine whether CDI recurrence is decreased in patients taking oral vancomycin as prophylactic therapy in addition to standard-of-care antibiotics that patients are taking for non-CDI reasons.	8 weeks
Secondary	Gut microbiome composition	Study how the gut microbiome is altered in patients receiving vancomycin treatment compared to placebo.	8 weeks
Secondary	Vancomycin-resistant enterococcus (VRE) colonization in patients receiving vancomycin vs. placebo	Low-dose exposure to vancomycin and VRE infection has not been studied. We will examine the incidence of VRE colonization in all patients and determine whether oral vancomycin increases the VRE colonization rate.	8 weeks
Secondary	Determine whether Clostridium difficile positivity on any stool sample is a predictor of CDI recurrence.	Stool samples will be tested at baseline, at the last dose date of vancomycin or placebo, at approximately 8 weeks following the last dose of vancomycin or placebo, and as indicated for diarrhea symptoms. Samples will be collected and tested for the presence of Clostridium difficile.	8 weeks