Nitazoxanide for the empiric treatment of pediatric infectious diarrhea.

We conducted a double-blind, placebo-controlled clinical trial to demonstrate the efficacy of nitazoxanide suspension for the treatment of presumed infectious diarrhea in children. Eligible patients must have had diarrheal illness lasting 3-29 days. Patients were randomized to receive either nitazoxanide or placebo twice daily for three days. The primary endpoint was time from first dose to resolution of symptoms. One hundred children mean age 3.3 years were enrolled. The median time to resolution of symptoms for nitazoxanide treated patients was 23 hours (IQR 4-48 hours) vs 103.5 hours (IQR 63->168 hours) for placebo (p<0.001). An analysis by disease subset indicated nitazoxanide treated patients had statistically shorter durations of diarrheal illness associated with Giardia lamblia (n=32, p<0.001) and those with no identified enteropathogen (n=38, p=0.008), when compared to placebo. The study medication was well tolerated. Overall, nitazoxanide was effective at reducing the duration of diarrheal illness associated with multiple etiologies, including patients with no identified enteropathogen. These results suggest nitazoxanide may be a viable therapeutic option for the empiric treatment of diarrheal illness in children where the etiology is unknown or presumed to be of infectious origin. Clinical trial registry number NCT01326338.