# Screening to Prophylax against C. difficile Infection (StoP CDI)

> **NIH AHRQ R01** · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · 2020 · $453,298

## Abstract

Abstract
Clostridium difficile infection (CDI) is the most common healthcare-associated infection (HAI), accounting for
12% of all HAIs. The Centers for Disease Control and Prevention has labeled CDI as one of three urgent
health threats that require immediate and aggressive action, as CDI is responsible for more than 450,000
hospitalizations and 29,000 deaths per year. Patients over 65 years old are most commonly affected and have
the highest mortality. C. difficile causes disease through production of toxins, and the increase in incidence,
severity, and mortality is in part due to the spread of a hypervirulent strain (NAP/BI/027) that produces more
toxin. Pre-existing colonization with toxigenic C. difficile is a risk factor for developing CDI. Use of antibiotics
that disrupt the protective normal colonic flora is the single largest risk factor for both C. difficile colonization
and CDI.
Current strategies to prevent CDI involve infection control measures to prevent transmission of C. difficile and
antibiotic stewardship to control antibiotic use. Ultimately, however, infection control cannot prevent cases of
CDI in patients already colonized. Thus, new measures need to be developed to identify patients at risk for CDI
due to toxigenic colonization and prevent progression to disease.
To date, no studies have considered primary prophylaxis as an approach to preventing CDI in appropriate
patients, despite the fact that prophylaxis is a universally accepted method of preventing other diverse
infections. In this study, we propose to screen patients who are initiating a course of antibiotics considered high
risk for CDI to determine who is colonized with toxigenic C. difficile and, therefore, at risk of developing CDI.
We hypothesize that the most effective and affordable intervention in the colonized patient population is
prophylactic treatment with vancomycin, which is efficacious against C. difficile. Our goal for this study is to
implement a first-of-its-kind clinical trial with the following specific aims:
 1) Determine the prevalence of toxigenic C. difficile colonization among the inpatient population treated with
 high-risk antibiotics and the incidence of CDI in these patients with respect to their state of colonization with
 C. difficile; and
 2) Determine the effect of vancomycin prophylaxis on patients receiving high-risk antibiotics who are
 colonized with toxigenic C. difficile based on molecular testing.
This clinical trial has the potential to cause transformative change in the methodology of preventing CDI and
alter the standard of care when using high-risk antibiotics in the hospital setting. This is a significant
contribution; this cost effective and easily implemented intervention has the potential to reverse the increasing
incidence of CDI and associated mortality rates, decrease the economic burden associated with the disease,
and improve patient quality of life with minimal discomfort and adverse impact to patients.

## Key facts

- **NIH application ID:** 10018912
- **Project number:** 5R01HS024951-05
- **Recipient organization:** WILLIAM BEAUMONT HOSPITAL RESEARCH INST
- **Principal Investigator:** Matthew David Sims
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $453,298
- **Award type:** 5
- **Project period:** 2016-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10018912

## Citation

> US National Institutes of Health, RePORTER application 10018912, Screening to Prophylax against C. difficile Infection (StoP CDI) (5R01HS024951-05). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10018912. Licensed CC0.

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