Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

Summary

This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group. As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

Timeline

Start

2024-06-05

Primary completion

2024-08-09

Completion

2024-08-09

Publications

• Sprecher VP, Schnoz A, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a single-blind, randomised, controlled, dose-ranging, phase 2 trial. Lancet Infect Dis. 2026 Feb;26(2):160-169. doi: 10.1016/S1473-3099(25)00472-4. Epub 2025 Sep 17.

Drugs

Indications