At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety and Acceptability of Ascending Doses of Ivermectin in Combination With Albendazole for Trichuris Trichiura Infections in Preschool-aged Children: a Single-blind Randomised Controlled Dose-ranging Trial
In Brief
A Phase 2 clinical trial evaluating Ivermectin 1.5 mg ODT, Ivermectin 3 mg Oral Tablet, and 2 other interventions for Trichuriasis and 2 related conditions. Completed, enrolled 260 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oro-dispersible tablets of 1.5 mg ivermectin
Tablets of 3 mg ivermectin
Tablets of 400 mg albendazole
Placebo for ivermectin ODT