At a glance
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Efficacy and Safety of Ivermectin and Albendazole Co-administration in School-aged Children and Adults Infected With Trichuris Trichiura: a Multi-country Randomized Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Albendazole and Albendazole and Ivermectin for Trichuriasis. Completed, enrolled 1,673 participants across 3 sites in 3 countries.
Detailed Summary
This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years). The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.
Study Details
Timeline
Interventions
Monotherapy of albendazole (400 mg)
Combination therapy of albendazole (400 mg) and ivermectin (200 µg/kg)