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Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection [Internet]

Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection [Internet]

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US)

Version: December 2011

Executive Summary

Clostridium difficile infection (CDI) is a serious healthcare-associated infection and a growing health care problem. C. difficile is a Gram-positive, spore-forming, anaerobic bacterium that, when ingested, can cause CDI if it is a toxigenic strain. CDI symptoms include varying levels of diarrhea severity, as well as pseudomembranous colitis and toxic megacolon. CDI incidence is estimated at 6.5 cases per 10,000 patient days in hospital. About 250,000 hospitalizations were associated with CDI in 2005. Direct attributable mortality from CDI has been reported to be as high as 6.9 percent of cases. Elderly people in hospitals account for the vast majority of severe morbidity and mortality. Residents of long-term care facilities are also at higher risk., Incidence rates may increase by fourfold or fivefold during outbreaks. In addition to institutional care environments, C. difficile is also common in the community, being easily isolated from soil and water samples. Community-associated CDI rates are generally much lower, accounting for 27 percent of all CDI cases in a recent prevalence study, but are also on the rise. However, the source of the C. difficile organisms responsible for cases of CDI in the community is not well understood.

Summary and Discussion

There is very limited high-quality evidence, to support the diagnostic, preventive, and treatment practices for Clostridium difficile infection (CDI) carried out by providers in hospital, long-term care, and outpatient settings. Inconsistency in definitions of diarrhea, severity, and resolution of symptoms contributes to the difficulty in drawing conclusions from the evidence. Table 22 provides a summary of the evidence and results presented in this review.


The topic for this report was nominated in a public process through the Agency for Healthcare Research Quality's nomination Web site. We drafted the initial key questions with input from a key informant panel composed of researchers; clinicians; professional organizations representing hospitals, infectious diseases, and clinicians; federal and state agencies; patient-safety advocates; and consumers. After approval from AHRQ, the key questions were posted to a public Web site. The public was invited to comment on these questions. After reviewing the public commentary and conferencing with the Technical Expert Panel (Appendix A), we drafted final key questions and submitted them to AHRQ for approval.


The general search identified 1,078 citations from MEDLINE. Of these, 356 studies were pulled for full text screening. Of these 356 references, we included 69 randomized controlled trials (RCTs), systematic reviews, observational studies, and an additional 22 articles obtained from hand searching and review article bibliographies. We excluded 998 articles. A supplemental search for diagnostics identified 519 citations from MEDLINE, of which 516 references were excluded. Figure 4 provides a literature flow diagram. A bibliography of the excluded articles, and their reasons for exclusion, is provided in Appendix D.

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