Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03462459|
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Clostridium Difficile Infection Clostridium Difficile Infection CDI C.Difficile Diarrhea C. Diff Colitis C.Difficile Colitis||Drug: Vancomycin Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
125 mg, oral capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Vancomycin capsule, 125 mg
Placebo Comparator: Placebo
125 mg placebo capsule by mouth, once daily, for the duration of standard-of-care antibiotic therapy plus 5 days
Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462459
|Contact: Joseph Perzynski, BSWfirstname.lastname@example.org|
|Contact: Michele L Zimbric, BSemail@example.com|
|United States, Minnesota|
|Division of Gastroenterology & Hepatology, Mayo clinic||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Rebecca Hotschulte 507-284-9709 firstname.lastname@example.org|
|Principal Investigator: Sahil Khanna, MBBS, MS|
|United States, Wisconsin|
|University of Wisconsin-Madison||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Kendra L Haight, BSN RN 608-262-6560 CDIstudy@medicine.wisc.edu|
|Contact: Shelly L Zimbric, BS 608-265-8799 email@example.com|
|Principal Investigator: Nasia Safdar, MD PhD|
|Principal Investigator:||Nasia Safdar, MD PhD||University of Wisconsin, Madison|