Summary 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.

Background: Enteric infection by Giardia intestinalis is a common cause of diarrhoea world‐wide and a significant cause of morbidity in children. Aim: To compare the efficacy and safety of nitazoxanide and metronidazole in the treatment of diarrhoea caused by G. intestinalis in children. Methods: A total of 110 children presenting with diarrhoea caused by G. intestinalis were randomized to treatment with either a 3‐day course of nitazoxanide (100 mg b.d., age range 2–3 years; 200 mg b.d., age range 4–11 years) or a 5‐day course of metronidazole (125 mg b.d., age range 2–5 years; 250 mg b.d., age range 6–11 years). The patients were followed‐up for a determination of clinical response 7 days after the initiation of treatment, and two subsequent stool samples were collected for parasitological examination. Results: Diarrhoea had resolved in 47 children out of 55 (85%) in the nitazoxanide treatment group before the day 7 follow‐up visit, compared to 44 out of 55 (80%) for metronidazole. Diarrhoea resolved within 4 days in most cases. Only mild, transient adverse events were reported. Conclusions: A 3‐day course of nitazoxanide suspension is as efficacious as a standard 5‐day course of metronidazole suspension in treating giardiasis in children.

Three randomized clinical studies were conducted in 2000 to evaluate the efficacy of nitazoxanide paediatric suspension compared to albendazole in the treatment of ascariasis and trichuriasis and praziquantel in the treatment of hymenolepiasis in children from Cajamarca, Peru. Nitazoxanide was administered at a dose of 100 mg (age 1-3 years) or 200 mg (age 4-11 years) twice daily for 3 days, albendazole as a 400-mg single dose and praziquantel as a 25-mg/kg single dose. Post-treatment parasitological examinations were carried out on 3 faecal samples, each collected on a different day between 21 and 30 days following initiation of treatment. Nitazoxanide cured 89% (25/28), 89% (16/18) and 82% (32/39) of the cases of ascariasis, trichuriasis and hymenolepiasis respectively compared with 91% (32/35), 58% (11/19) and 96% (47/49) for the comparator drugs. Each of the drugs produced egg reduction rates in excess of 98%. There were no significant adverse events or abnormalities in haematology or clinical chemistry values or urinalysis.