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

Abstract

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.

Human liver flukes

“…Nitazoxanide is considered second line treatment for human fascioliasis by the CDC (116) . Cure rates of 60% in adults and 40% of children with F. hepatica infection have been reported (127) . A study of Mexican children with F. hepatica infection, produced cure rates of 94% with nitazoxanide 7.5mg/kg twice daily, for 7 days, rising to 100% with a second treatment course (128) .…”

Evaluation of Nitazoxanide for the Treatment of Disseminated Cystic Echinococcosis: Report of Five Cases and Literature Review

“…It has activity against a wide variety of microorganisms affecting humans including intestinal parasites, enteric bacteria, and the hepatitis C virus. [13][14][15][16][17] It was initially developed as a veterinary antihelminthic agent against intestinal cestodes and was first described in 1984 as a human cestocidal drug. 18 Additionally, there is in vitro and in vivo evidence that supports the efficacy of nitazoxanide against metacestodes of E. granulosus 19,20 and Echinococcus multilocularis .…”

Comparative parasitological and electron microscopic studies on the effects of Nitazoxanide and Praziquantel in Schistosoma mansoni-infected mice

“…The recommended dose of NTZ is 500 mg in adults and adolescents, 200 mg in children aged 4-11 years and 100 mg in children aged 1-3 years; the dose was given twice daily for three days. (Stockis A et al 2002) The anthelmintic activity was tested against cestodes Maisonneuve H 1984, Stettler M et al 2003) as Taenia, Hymenolepis, Echinococcus, for trematodes as in Fasciola (Rossignol JF et al 1998, Favennec L et al 2003) and for nematodes , Diaz E et al 2003 as in Ascaris, Trichuris and Strongyloides with promising results. These advances prompted NTZ to be ranked as a broad-spectrum anthelmintic drug and eventually a broad-spectrum anti-parasitic drug (Fox LM …”