Moxidectin-STH - Efficacy and safety of moxidectin plus albendazole, moxidectin plus tribendimidine, albendazole plus oxantel pamoate and moxidectin alone against Trichuris trichiura and concomitant soil-transmitted helminth infections: a randomized controlled trial
The recommended anthelmintics show low efficacy in a single-dose regimen against Trichuris trichiura. Moxidectin, a new treatment for river blindness, might complement the drug armamentarium for the treatment an control of soil-transmitted helminthiasis. However, its efficacy against T trichiura has not yet been studied. The aim of the study was to assess the efficacy of moxidectin alone and in co-administrations against T trichiura infection.
A randomised, single-blind, non-inferiority trial will be done in two primary schools and one secondary school in Pemba, Tanzania. Adolescents aged 12–18 years who tested positive for T. trichiura are randomly assigned to receive moxidectin (8 mg) plus albendazole (400 mg), albendazole (400 mg) plus oxantel pamoate (25 mg/kg; reference treatment), moxidectin (8 mg) plus tribendimidine (200 mg or 400 mg), or moxidectin (8 mg) alone. Study group assignments are masked from participants and laboratory technicians. The primary outcome is non-inferiority with a 2 percentage point margin for egg reduction rate (ERR) against T. trichiura assessed as the relative change in the geometric mean egg counts from baseline to 14–21 days after treatment with the Kato-Katz method, based on the available case population. Cure rates (CR) and tolerability (assessed 3, 24, and 48 h post treatment) are secondary outcomes. The study is registered at ISRCTN (number 20398469).
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Barda B, Ame M.S, Ali M.S, Albonico M, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and tolerability of moxidectin alone and in co-administration with albendazole plus oxantel pamoate against Trichuris trichiura infections: a randomised, non inferority, single-blind trial. Lancet Infect Dis. 2018;18(8):864-873. DOI: 10.1016/S1473-3099(18)30233-0