At a glance
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Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children: a Double-blind Randomised Controlled Superiority Trial
In Brief
A Phase 3 clinical trial evaluating Moxidectin 2 mg Oral Tablet, Albendazole 400 mg Oral Tablet, and 2 other interventions for Trichuriasis and 2 related conditions. Completed, enrolled 224 participants across 1 site.
Detailed Summary
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC. As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Study Details
Timeline
Interventions
Tablets of 2 mg moxidectin
Tablets of 400 mg albendazole
Placebo tablets for moxidectin
Placebo tablets for albendazole