At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial
In Brief
A Phase 3 clinical trial evaluating moxidectin (8 mg) / albendazole (400 mg), ivermectin (200 µg/kg) / albendazole (400 mg), and 3 other interventions for Trichuriasis and 3 related conditions. Completed, enrolled 536 participants across 1 site.
Detailed Summary
The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura. The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment. This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).
Study Details
Timeline
Interventions
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0