# Fluoroquinolone Restriction for the Prevention of C. difficile Infection (CDI)_the FIRST Trial.

> **NIH AHRQ R01** · UNIVERSITY OF WISCONSIN-MADISON · 2020 · $498,021

## Abstract

Abstract
Each year, Clostridium difficile infection (CDI) affects 453,000 Americans, causes 29,000 deaths, and leads to
an estimated $4.8 billion in excess costs in acute care hospitals within the US. Effective infection control
measures and antibiotic stewardship (AS) are fundamental to sustained control of CDI in healthcare settings.
There is an urgent need to identify and implement AS strategies that specifically target CDI by focusing on
reducing use of antibiotics highly associated with increased risk of CDI, such as fluoroquinolones (FQ).
Preprescription authorization (PPA) and postprescription review with feedback are two core AS strategies.
However, it is unclear 1) which AS strategies are most effective in reducing CDI specifically and 2) how to
implement AS strategies effectively. Without addressing these critical gaps, CDI prevention will continue to lag.
The objective of the proposed study is to evaluate the effectiveness and implementation of a FQ PPA as an AS
strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the transmission of resistant
bacteria. This will contribute to the long-term goal of reducing the burden of CDI, which is an essential step in
improving the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to reduce CDI.
Although FQs are one of the most frequently utilized classes of antibiotics in inpatient acute care facilities and
are closely associated with risk for CDI, FQ usage has not been the focus of control efforts in endemic settings
in the US. The proposed study will use an effectiveness-implementation hybrid type 2 design to simultaneously
evaluate the efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for
implementing such an intervention successfully. Intensive care units in acute care hospitals throughout
Wisconsin will participate in this stepped wedge cluster randomized controlled trial. The specific aims for the
proposed study are to: 1) determine the impact of a FQ PPA on hospital-onset and healthcare-associated CDI
rates and other clinical outcomes compared with usual care; and 2) evaluate the implementation of FQ PPA
using a systems engineering approach. For aim 1, electronic health record data will be used to evaluate the
impact of the FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical
outcomes. For aim 2, surveys and interviews with healthcare providers will be used to evaluate the contextual,
implementation, and work system factors that contribute to successful implementation of a FQ PPA
intervention. In addition to addressing an urgent need to identify effective AS strategies, this study will provide
a framework to implement and evaluate other interventions for HAI prevention. Regardless of the results, the
proposed study will generate data, tools and methods with widespread applicability for AS initiatives in
healthcare-associated infection prevention.

## Key facts

- **NIH application ID:** 9928002
- **Project number:** 5R01HS026226-03
- **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:** $498,021
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928002

## Citation

> US National Institutes of Health, RePORTER application 9928002, Fluoroquinolone Restriction for the Prevention of C. difficile Infection (CDI)_the FIRST Trial. (5R01HS026226-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9928002. Licensed CC0.

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