Rotavirus is a leading cause of morbidity and mortality in children younger than 5 years, but there is no effective treatment.
Professor Jean-François Rossignol and colleagues assessed the activity of nitazoxanide for severe rotavirus diarrhea.
The investigative team evaluated the effect of this broad-spectrum anti-infective drug against rotavirus in cell cultures and in a clinical trial in pediatric patients.
The team conducted a randomized double-blind placebo-controlled trial in 50 children.
The patients were admitted to the Cairo University Children's Hospital in 2005 with severe rotavirus diarrhea.
The team included 38 children aged 5 months to 7 years.
| Median time to illness resolution was 31 hours with nitazoxanide vs 75 hours with placebo|
Rotavirus was the sole identified cause of gastroenteritis in these children.
Patients were randomly assigned either 7.5 mg/kg nitazoxanide as an oral suspension or placebo twice a day for 3 days.
All patients remained in hospital for 7 days after start of treatment.
The team's primary endpoint was time from first dose to resolution of illness, and analysis was by modified intention-to-treat.
Survival analysis showed that the median time to resolution of illness was 31 hours for the nitazoxanide-treated group vs 75 hours for the placebo group.
The investigators noted no significant adverse events.
The team observed that a 3-day course of nitazoxanide significantly reduced the duration of rotavirus disease in hospitalized pediatric patients.
Professor Rossignol's team concluded, “These results are encouraging, and might lead us to think about new approaches to managing rotavirus disease in children.”