# Efficacy of oral vancomycin prophylaxis for prevention of recurrent C. difficile infection

> **NIH AHRQ R01** · UNIVERSITY OF WISCONSIN-MADISON · 2020 · $474,458

## Abstract

Clostridium difficile (C. difficile) is a pathogen of major public health importance and the most
common cause of healthcare-associated diarrhea, with high rates of recurrent disease,
especially in those re-exposed to antimicrobial therapy. Data from the Centers for Disease
Control and Prevention estimate that in 2011 there were 453,000 incident episodes of C. difficile
infections (CDI) resulting in 29,300 deaths. The annual cost from CDI in the US is estimated at
1.3 billion dollars. Unfortunately, nearly one third of patients who develop initial infection will
develop recurrence, and risk of subsequent recurrence increases with each episode. Antibiotics
given for other infectious conditions may trigger CDI recurrence after resolution of initial CDI
episode. Preventing CDI recurrence is essential to reduce the myriad physical, social, and
psychological consequences that accompany recurrent episodes. Prophylaxis with vancomycin
may reduce risk of recurrence but has not been well studied. We propose a multicenter placebo-
controlled double blind randomized controlled trial (RCT) in 150 subjects to evaluate the efficacy
of prophylaxis with 125 mg daily oral vancomycin versus placebo for preventing recurrent CDI in
patients who have experienced at least one CDI episode in the last 90 days and are receiving
antibiotics for a non CDI condition. In addition, we will evaluate the impact of this treatment on
the gut microbiota composition and function and gut colonization by vancomycin-resistant
enterococcus (VRE). Subjects will be followed for 8 weeks after completing vancomycin or
placebo treatment. The primary outcome will be recurrent CDI. Procedures will include
collection of at least 3 stool samples, and completion of stool diaries throughout the study with 3
study visits (baseline, completion of oral vancomycin and at 8 weeks following the end of
therapy). Study findings will not only determine the efficacy of oral vancomycin prophylaxis, but
also provide insight into the effect of oral vancomycin on the fecal microbiota and VRE
colonization. With the critical importance of antibiotic stewardship, it is important to examine the
trade-off between a potential benefit and possible adverse effects such as gut dysbiosis. If oral
vancomycin prophylaxis is found to be efficacious it will shift the current paradigm in the
approach to prevention of recurrent CDI.

## Key facts

- **NIH application ID:** 9948646
- **Project number:** 5R01HS025713-04
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** NASIA SAFDAR
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $474,458
- **Award type:** 5
- **Project period:** 2017-09-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9948646

## Citation

> US National Institutes of Health, RePORTER application 9948646, Efficacy of oral vancomycin prophylaxis for prevention of recurrent C. difficile infection (5R01HS025713-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9948646. Licensed CC0.

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