Back to resultsEfficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Primary Purpose
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Clostridium Difficile Infection focused on measuring Oral vancomycin, vancomycin, antibiotic
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin-Madison
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vancomycin
Placebo
Arm Description
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Gut microbiome composition
Study how the gut microbiome is altered in patients receiving vancomycin treatment compared to placebo.
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.
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.
Full Information
NCT ID
NCT03462459
First Posted
February 28, 2018
Last Updated
July 26, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Medical College of Wisconsin, Agency for Healthcare Research and Quality (AHRQ), Henry Ford Hospital, Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03462459
Brief Title
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Official Title
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Medical College of Wisconsin, Agency for Healthcare Research and Quality (AHRQ), Henry Ford Hospital, Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea, C. Diff Colitis, C.Difficile Colitis
Keywords
Oral vancomycin, vancomycin, antibiotic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancomycin Hydrochloride, Vancocin
Intervention Description
Vancomycin capsule, 125 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
Primary Outcome Measure Information:
Title
Recurrent Clostridium difficile infection (CDI)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Gut microbiome composition
Description
Study how the gut microbiome is altered in patients receiving vancomycin treatment compared to placebo.
Time Frame
8 weeks
Title
Vancomycin-resistant enterococcus (VRE) colonization in patients receiving vancomycin vs. placebo
Description
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.
Time Frame
8 weeks
Title
Determine whether Clostridium difficile positivity on any stool sample is a predictor of CDI recurrence.
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasia Safdar, MD PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
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