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Updated: Jun 12, 2026
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A Protocol to Characterize the Morphological Changes of Clostridium difficile in Response to Antibiotic Treatment
Published on: May 25, 2017
Semi-automated risk estimation using large databases: quinolones and Clostridium difficile associated diarrhea
Robertino M Mera1, Kathleen J Beach, Gregory E Powell
1GlaxoSmithKline, Research Triangle Park, NC 27709, USA. robertino.mera@gsk.com
Pharmacoepidemiology and Drug Safety
|June 11, 2010
Summary
Fluoroquinolones significantly increase the risk of Clostridioides difficile-associated diarrhea (CDAD). A semi-automated pharmacovigilance method rapidly identified this association using large databases.
Area of Science:
- Pharmacovigilance
- Epidemiology
- Medical Informatics
Background:
- Large databases with person-time information enable rapid pharmacovigilance.
- Semi-automated methods can efficiently analyze drug safety signals.
Purpose of the Study:
- To investigate the association between fluoroquinolone use and Clostridioides difficile-associated diarrhea (CDAD) incidence.
- To evaluate a semi-automated methodology for pharmacovigilance analysis.
Main Methods:
- Utilized two US databases (EMR and claims, 2006-2007) with a semi-automated approach.
- Normalized drug exposures (Snowmed) and conditions (MedDRA) using ontologies.
- Employed a retrospective cohort design with propensity score matching and Poisson regression.
Main Results:
- Compared quinolone exposure (564,797 in claims, 233,090 in EMR) against macrolides.
- Identified a significantly higher association between quinolones and CDAD (IRR 2.75, 95%CI 2.18-3.48).
- Observed 488 CDAD outcomes in claims and 158 in EMR among matched cohorts.
Conclusions:
- Successfully applied a semi-automated method to observational databases for rapid safety signal detection.
- Confirmed a potential increased risk of CDAD associated with quinolone use.
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