Clostridium difficile infections (CDIs) are associated with significantand debilitating morbidity and can result in severe outcomes such as surgical intervention or death. Theprimary modifiable risk factor for CDI is antimicrobial use. The proposed research will focus on the risk ofinfection following the use of fluoroquinolones, an antimicrobial class associated with CDI outbreaks. Wepropose to develop a risk score for the prediction of CDI among patients who receive a fluoroquinoloneprescription in the outpatient setting. Our long-term goal is to enhance the safe use of fluoroquinolone agentsin the outpatient setting by providing risk information to clinicians at the time of prescribing through alertsembedded in the electronic medical record. These alerts will provide patient-level prediction of CDI risk to aidclinician decision-making when a fluoroquinolone prescription is being considered. The incorporation of thisrisk score into an alert will offer a more accurate risk management strategy than asking the clinician tosynthesize a patient's individual predictors of CDI on an ad hoc basis. The objectives of this application areto quantify the risk for CDI following fluoroquinolone use and to develop a risk score to identify patients athigh-risk patient for CDI. To accomplish these objectives, we propose the following specific aims: (1)Describe the epidemiology of Clostridium difficile infections in patients who filled a fluoroquinoloneprescription in the outpatient setting; and, (2) Develop a risk score to predict Clostridium difficile infectionamong a cohort of patients who are prescribed fluoroquinolones in the outpatient setting using patientdemographic and clinical characteristics available through automated means from the electronic medicalrecord. To accomplish these aims, we will identify a retrospective inception cohort of patients prescribed afluoroquinolone in the outpatient setting and, among this cohort, describe the epidemiology of CDI in the sixmonths following fluoroquinolone use. A CDI risk score will then be developed from patient characteristics topredict the risk of CDI among this cohort and to categorize patients by their predicted risk for CDI. Thisproject has potential to significantly reduce the significant mortality and morbidity associated with CDIinfection by improving prescribing practices of fluoroquinolones. Our preliminary data show that 29% of CDIsoccurred subsequent to fluoroquinolone use. Eventually, if this risk score can be successfully used byclinicians to prescribe fluoroquinolones to patients at lower risk for CDI only, we plan to adapt this researchto develop risk scores based on EMR data for other adverse outcomes.

Public Health Relevance

The aim of this study is to better understand which patients are at risk for infection with a bacterium called Clostridium difficile. Clostridium difficile infection (CDI) causes severe damage to the stomach and intestines, so severe that surgery is often necessary for treatment, and can even lead to death. The main risk factor for developing this infection is treatment with certain types of antimicrobial (antibiotic) drugs. The goal of our study is to help physicians who are considering prescribing a specific type of antimicrobial, a fluoroquinolone, decide which patients are at high risk for CDI, by developing a risk score for each patient based on information available from electronic medical records. We will use demographic and clinical information about patients who have been prescribed a fluoroquinolone, to help predict which patients are most at risk for CDI.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD004258-01
Application #
8301276
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2011-09-15
Project End
2012-09-14
Budget Start
2011-09-15
Budget End
2012-09-14
Support Year
1
Fiscal Year
2011
Total Cost
Indirect Cost
Name
Kaiser Foundation Research Institute
Department
Type
DUNS #
150829349
City
Oakland
State
CA
Country
United States
Zip Code
94612