Nitazoxanide: Potential New Tool for Treating Rotavirus Diarrhea

Summary and Comment |
July 12, 2006

Nitazoxanide: Potential New Tool for Treating Rotavirus Diarrhea

  1. Mary E. Wilson, MD

An oral suspension of nitazoxanide significantly shortened the duration of severe rotavirus diarrhea in hospitalized children in Egypt.

  1. Mary E. Wilson, MD

Rotavirus is a common cause of severe diarrhea worldwide and the most common cause of diarrheal deaths in children <5 years old in developing areas. Highly effective rotavirus vaccines have been licensed in several countries but are currently unavailable to most children, so effective treatments for rotavirus infection are needed. Researchers showed that tizoxanide, the active metabolite of nitazoxanide, was active against rotavirus in cell culture, protecting cells against the cytopathic effects of rotavirus. They then conducted an industry-supported, randomized, double-blind trial of nitazoxanide among rotavirus-infected children in Cairo.

Fifty children <12 years old hospitalized with severe rotavirus diarrhea were enrolled and treated with an oral suspension of nitazoxanide (7.5 mg/kg for patients <12 months, 100 mg for those 12–47 months, 200 mg for those 4–11 years; administered twice daily for 3 days) or placebo. Stool samples were tested for viruses, examined for ova and parasites, and cultured for bacteria. Enrollees were observed in the hospital for 7 days and followed for a total of 14 days. Thirty-eight children (median age, 11 months) for whom rotavirus was the sole identified cause of diarrhea were included in the efficacy analysis. Thirty-one (82%) were malnourished, as indicated by being underweight, and 30 (79%) had vomiting. On follow-up, the time from start of treatment to resolution of illness was significantly shorter for nitazoxanide recipients than for placebo recipients (median, 31 vs. 75 hours).

Comment

This study is limited by its small size and by the absence of tests to detect all pathogens against which nitazoxanide might be active (e.g., Clostridium difficile). On the plus side, the drug is well tolerated, can be taken orally, is already available in many developing countries, and is licensed in the U.S. for treatment of cryptosporidiosis and giardiasis. If its efficacy against rotavirus infection is confirmed in larger, independent studies, nitazoxanide would be a welcome additional tool for managing this condition. Eventually, vaccine should become the primary approach worldwide for reducing the burden from rotavirus disease, although cost will be a major obstacle in reaching this goal.

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