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Trial record 6 of 534 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT03462459
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
Indiana University
Medical College of Wisconsin
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE February 28, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE May 21, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
Recurrent Clostridium difficile infection (CDI) [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03462459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Gut microbiome composition [ Time Frame: 8 weeks ]
    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 [ Time Frame: 8 weeks ]
    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. [ Time Frame: 8 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Official Title  ICMJE Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Recurrent Clostridium Difficile Infection
  • Clostridium Difficile Infection
  • CDI
  • C.Difficile Diarrhea
  • C. Diff Colitis
  • C.Difficile Colitis
Intervention  ICMJE
  • Drug: Vancomycin
    Vancomycin capsule, 125 mg
    Other Names:
    • Vancomycin Hydrochloride
    • Vancocin
  • Drug: Placebo
    Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
Study Arms  ICMJE
  • Experimental: Vancomycin
    125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
    Intervention: Drug: Vancomycin
  • Placebo Comparator: Placebo
    125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kendra Haight, RN 608-262-6560 CDIstudy@medicine.wisc.edu
Contact: Michele L Zimbric, BS 608-265-8799 mzimbric@medicine.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462459
Other Study ID Numbers  ICMJE 2017-0927
1R01HS025713-01 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • Indiana University
  • Medical College of Wisconsin
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Nasia Safdar, MD PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP