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Nitazoxanide Appears Effective Against Clostridium Difficile Disease: Presented at DDW
A pilot study shows that nitazoxanide might work to treat Clostridium difficile, which means that it could become an alternative to vancomycin -- the only drug that has US Food and Drug Administration labelling for treatment of the stubborn illness.
The research was presented in a poster presentation on May 21 here at the Digestive Disease Week 2008 (DDW).
"Clostridium difficile disease has emerged as a major nosocomial infection in the developed world, with well-documented increases in incidence and severity," said investigator Daniel M. Musher, MD, Professor of Medicine - Infectious Diseases, Baylor College of Medicine, Houston, Texas.
"We and others have shown a substantial rate of failure of treatment with metronidazole," Dr. Musher noted. "Nearly 25% of hospitalised patients fail to respond and another 25% have recurrence of infection after an initial response."
"Documentation of failures with metronidazole has increased reliance on vancomycin," he added. "However, cost considerations and concern that increased vancomycin usage will facilitate emergence of vancomycin-resistant organisms in the hospital environment have motivated an ongoing search for alternative therapy."
Dr. Musher and colleagues at 10 centres in the United States treated 27 patients with vancomycin 125 mg 4 times daily and 22 patients with nitazoxanide (1 patient was excluded due to comorbidities) 500 mg twice daily.
The aim of the study was to evaluate the drugs' efficacy in eliminating all symptoms of disease within 12 to 14 days. Two-thirds of the patients were male, and 42 of the 49 were hospitalised. More of the patients in the nitazoxanide group were African Americans, but the difference was not statistically significant (P = .06).
The nitazoxanide patients had a mean age of 59.6 years compared with 65.7 years for the vancomycin patients, a nonsignificant difference (P = .11).
Dr. Musher reported that 66.7% of vancomycin patients achieved sustained response compared with 72.7% of nitazoxanide patients, a nonsignificant difference. The time to complete resolution of symptoms also failed to achieve statistical significance (P = .56).
Relapses occurred in 2 vancomycin patients and 1 nitazoxanide patient within 31 days of treatment.
Although the study was not designed to determine whether nitazoxanide is noninferior to vancomycin, Dr. Musher said, "Nevertheless, this is the first recent randomised, controlled trial comparing any antimicrobial agent other than metronidazole with vancomycin."
Previous studies of metronidazole showed this agent to be inferior to vancomycin.
"Results suggest that nitazoxanide may be as effective as vancomycin in treating C. difficile," Dr. Musher concluded.