Journal Article

Prospective, Randomized Inpatient Study of Oral Metronidazole versus Oral Metronidazole and Rifampin for Treatment of Primary Episode of <i>Clostridium difficile</i>–Associated Diarrhea

Danny Lagrotteria, Serena Holmes, Marek Smieja, Fiona Smaill and Christine Lee

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 43, issue 5, pages 547-552
Published in print September 2006 | ISSN: 1058-4838
Published online September 2006 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/506354
Prospective, Randomized Inpatient Study of Oral Metronidazole versus Oral Metronidazole and Rifampin for Treatment of Primary Episode of Clostridium difficile–Associated Diarrhea

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Background. To date, no randomized trial to address the use of adjunctive rifampin in addition to metronidazole for the treatment of Clostridium difficile–associated diarrhea has been reported. Rifampin has excellent in vitro activity against C. difficile and penetrates into cellular materials where the organisms may persist.

Methods. This was a prospective, randomized, single-blinded study of 39 patients that compared therapy with metronidazole alone versus therapy with metronidazole and rifampin for 10 days to treat laboratory-confirmed primary episode C. difficile–associated diarrhea. Twenty patients were randomly assigned to the metronidazole group, and 19 were randomly assigned to the metronidazole and rifampin group. Data were analyzed by intention-to-treat analysis using the 2-tailed Kaplan-Meier method and the log-rank test.

Results. Adjunctive rifampin treatment for 10 days, compared with treatment with metronidazole alone for 10 days, was associated with a similar median time to symptom improvement (9.0 days vs. 6.5 days; P = .74), a similar median time to first relapse (26 days vs. 16 days; P = .23), a similar proportion of patients with relapse by study day 40 (42% vs. 38%; P = 1.0), and a similar proportion of patients experiencing nonfatal adverse events (37% vs. 40%; P = .55). There were a significantly higher number of deaths in the metronidazole and rifampin group, compared with the metronidazole group (6 of 19 patients vs. 1 of 20 patients; P = .04), but there were fewer laboratory-confirmed relapses by study day 40 (2 vs. 4; P = .66).

Conclusions. We conclude that there is no role for routine rifampin as an adjunct to treatment with metronidazole for hospitalized patients with C. difficile–associated diarrhea. The cure rates for both treatment groups remain unacceptably low, and better treatments are urgently needed.

Journal Article.  2940 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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