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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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