Phase 2 Study Comparing Different Doses of Oxfendazole and a Single Dose of Albendazole for Treating Trichuris Trichiura Infection in Adults

What this Trial Is About

Researchers are evaluating the effectiveness of different doses of oxfendazole compared to a single dose of albendazole in treating adults infected with Trichuris trichiura, a type of intestinal parasite. This Phase 2 trial aims to determine which dose better cures or reduces the parasite egg burden. The study involves 249 participants from Iquitos, Peru, and nearby villages with a high prevalence of this infection. Laboratory staff assessing stool samples will be blinded to treatment groups, while participants and study staff will know their assigned dose. Participants will be randomly assigned to one of three groups a single oral dose of oxfendazole 400 mg, oxfendazole 800 mg, or albendazole 400 mg. Water and a snack will be provided to help take the medication, and ingestion will be observed by study personnel. The study includes a two-step screening process to confirm infection and eligibility. If participants have other parasites or choose not to join, they will be referred to local health providers for standard care. During the trial, participants will provide stool and blood samples over about 4 to 6 weeks to assess treatment effects. Researchers will measure cure rates by checking for the absence of parasite eggs in stool using the Kato-Katz method between days 18 and 23 after treatment. They will also evaluate egg counts, infection intensity changes, safety, tolerability, and effects on other intestinal parasites. If parasites are detected at study end, participants will be contacted for referral to local care. The study includes safety monitoring up to day 23 after dosing.

A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults