Effect of nitazoxanide for treatment of severe rotavirus diarrhoea: randomised double-blind placebo-controlled trial.

Background: Rotavirus is a leading cause of morbidity and mortality in children younger than 5 years, but there is no effective treatment. We assessed the activity of nitazoxanide, a broad-spectrum anti-infective drug, against rotavirus in cell culture and in a clinical trial in paediatric patients hospitalised with severe rotavirus diarrhoea.

Methods: We did a randomised double-blind placebo-controlled trial in 50 children admitted to the Cairo University Children's Hospital between June 15 and Aug 23, 2005, with severe rotavirus diarrhoea. 38 children aged 5 months to 7 years (median age 11 months) with rotavirus as the sole identified cause of gastroenteritis were enrolled in the clinical study. Patients were randomly assigned either 7.5 mg/kg nitazoxanide as an oral suspension or placebo twice a day for 3 days, and all remained in hospital for 7 days after start of treatment. The primary endpoint was time from first dose to resolution of illness, and analysis was by modified intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00302640.

Findings: Survival analysis showed that the median time to resolution of illness was 31 h (IQR 22-73) for the nitazoxanide-treated group compared with 75 h (51-124) for the placebo group (p=0.0137). No significant adverse events were reported.

Interpretation: A 3-day course of nitazoxanide significantly reduced the duration of rotavirus disease in hospitalised paediatric patients. These results are encouraging, and might lead us to think about new approaches to managing rotavirus disease in children.