Among patients with Clostridium difficile infection (CDI) who recovered following standard treatment with the antibiotics¹ metronidazole or vancomycin, oral administration of spores² of a strain of C difficile that does not produce toxins⁴ colonized⁶ the gastrointestinal tract⁷ and significantly reduced CDI recurrence⁸, according to a study in the May 5 issue of JAMA. C difficile is the cause of one of the most common and deadly health care-associated infections, linked to 29,000 U.S. deaths each year. Rates of CDI remain at unprecedented⁹ high levels in U.S. hospitals. Clinical infection also has a recurrence rate of 25 percent to 30 percent among affected¹⁰ patients. Not all strains of C difficile produce toxins. Nontoxigenic C difficile strains that lack the genes¹¹ for toxin³ production are also found in the hospital environment and can colonize⁵ hospitalized patients, although patients are usually asymptomatic. Gastrointestinal colonization¹² by these nontoxigenic C difficile strains (in both humans and hamsters) has shown promising¹³ results as a potential way to prevent CDI, according to background information in the article.

 

Dale N. Gerding, M.D., of the Edward Hines Jr. VA Hospital, Hines, Il., and Loyola University Chicago, Maywood, Il., and colleagues randomly¹⁴ assigned 173 adult patients who were diagnosed as having CDI (first episode or first recurrence) to receive 1 of 4 treatments: oral liquid formulation of nontoxigenic C difficile strain M3 (VP20621; NTCD-M3), 104 spores/d for 7 days (n = 43), 107 spores/d for 7 days (n = 44), 107 spores/d for 14 days (n = 42), or placebo¹⁵ for 14 days (n = 44). Prior to enrollment¹⁶, these patients had all successfully completed treatment with metronidazole, oral vancomycin, or both at 44 study centers in the United States, Canada, and Europe.

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