Double-blind, randomized, placebo-controlled study of nitazoxanide in the treatment of fascioliasis in adults and children from northern Peru.

BACKGROUND: Human fascioliasis is a significant world-wide health problem, and massive or repeated infections by Fasciola hepatica can lead to considerable morbidity.

AIM: : To evaluate the safety and efficacy of nitazoxanide, when compared with placebo, in the treatment of fascioliasis in adults and children from northern Peru.

METHODS: A double-blind, placebo-controlled study was carried out in 50 adults and 50 children infected with F. hepatica. The diagnosis of infection was based on the presence of F. hepatica eggs in one stool sample obtained before inclusion in the study. Patients were randomized to receive treatment with either a 7-day course of nitazoxanide (100 mg b.d., age range 2-3 years; 200 mg b.d., age range 4-11 years; 500 mg b.d., age > 12 years) or matching placebo. Three post-treatment stool examinations were carried out between 30 and 90 days after initiation of treatment.

RESULTS: The parasite was eliminated in 18 of 30 (60%) adults completing the study who received nitazoxanide vs. one of eight adults in the placebo group (P = 0.042), and similarly in 14 of 35 (40%) children completing the treatment vs. none of eight in the placebo group (P = 0.038). Only mild, transient adverse events were reported.

CONCLUSIONS: A 7-day course of nitazoxanide was effective in adults and children in the treatment of F. hepatica, when compared with placebo.