Testing Safety and Effectiveness of Different Doses of Arpraziquantel for Treating Opisthorchis Viverrini Infection in Children Aged 6 to 7 Years

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and acceptability of different doses of arpraziquantel in children aged 6 to 7 years who are infected with Opisthorchis viverrini. This parasite infection is common in young children and often goes untreated in current public health programs. The main goal is to understand how various doses affect the cure rate of the infection. Participants will receive a single oral dose of arpraziquantel at one of several ascending dose levels 20, 30, 40, 50, or 60 mg per kg of body weight. This dose-ranging trial is randomized and single-blind, with children assigned to one of these dosing groups. The study will assess the response after treatment and monitor safety at multiple time points. Children will be asked to provide stool samples before treatment and again 21 to 28 days afterward to measure cure rates and egg reduction rates. Safety and tolerability will be monitored at 3 hours, 24 hours, 21-28 days, and 42 days after treatment. The study participation involves follow-up assessments to collect these samples and monitor health, lasting up to about six weeks after treatment.

Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini