Randomized trial of a single, double and triple dose of 10 mg/kg of a human formulation of triclabendazole in patients with fascioliasis.

1. A study performed > 10 years ago and case reports published recently suggest that triclabendazole is effective for the treatment of patients with fascioliasis. 2. To confirm the efficacy of a human formulation of triclabendazole, we enrolled 165 patients into the present study and divided the subjects into two groups: (i) those who had fascioliasis, as evidenced by the presence of ova in their stools; and (ii) patients with clinical and laboratory data suggesting fascioliasis. 3. Patients were randomly allocated to receive 10 mg/kg, p.o., triclabendazole for 1, 2 or 3 days (single-, double- and triple-dose groups, respectively). Medical history and physical and laboratory examinations were performed at baseline and at 7, 14, 30 and 60 days after treatment. Results were based on 152 patients who completed the study. 4. A sharp decrease in the proportion of clinical signs and symptoms was observed in all groups immediately after treatment. Ova disappeared from the stools of all patients in the single- and double-dose groups. Thirty days after treatment, ova were identified in the stools of two patients in the triple-dose group who received a second course of triclabendazole. 5. All cases were cured on day 60. However, the cure rate was lower when the patients with suggestive fascioliasis were included in the analysis. The cure rate was not significantly different (P > 0.05) among the three dose groups. No cases of toxic hepatitis were observed. 6. In conclusion, oral administration of 10 mg/kg of the human pharmaceutical preparation of triclabendazole for 1-3 days is safe and effective in the treatment of human fascioliasis.

RCT Entities:   Population Interventions Outcomes