An open-label clinical study of nitazoxanide in the treatment of human fascioliasis

Abstract

Abstract Objective The aim of the study was to assess the efficacy of nitazoxanide, a broad-spectrum antiparasitic agent, in the treatment of chronic human fascioliasis. Background Human fascioliasis has become a significant public health concern in Egypt. No single treatment for human fascioliasis is widely recognized as safe and effective. Methods We studied 125 patients from the Menoufiya Governorate in the Nile Delta of lower Egypt. Each patient had clinical symptoms consistent with fascioliasis, including fever, anorexia, nausea, pain in the right hypochondrium, abdominal pain, hepatomegaly, and hepatosplenomegaly; and chronic fascioliasis was diagnosed in each based on the presence of Fasciola hepatica eggs in the feces. Nitazoxanide was administered as a 500-mg (200-mg for children) tablet twice daily (morning and evening) for 6 consecutive days with food. On days 4, 6, and 30 after the initiation of treatment, a physical examination was conducted, fecal samples were collected for parasitologic examination, and a blood sample was collected for serology using Fasciola gigantica antigens. On day 6, a blood sample was submitted for hematology and clinical chemistry analyses, and a urinalysis was performed. Efficacy was assessed based on parasitologic examination of a stool sample obtained 30 days after initiation of treatment. Results These examinations showed that 121 of the 125 patients were free of F hepatica eggs in the stool samples taken on day 30. Serological titers and eosinophil counts also decreased in a manner consistent with eradication of the infection. The drug was well tolerated. Conclusions Results of the present study suggest that nitazoxanide is safe and efficacious in the treatment of human fascioliasis. However, further controlled clinical trials should be conducted to confirm this conclusion.