Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected withTrichuris trichiura : a randomized controlled trial protocol

Gates Open Research

article

Sophie Welsche¹  Emmanuel C. Mrimi¹  Ladina Keller¹  Eveline Hürlimann¹  Daniela Hofmann¹  Jan Hattendorf¹  Said M. Ali³  Jennifer Keiser¹ 

[1] Swiss Tropical and Public Health Institute;University of Basel;Public Health Laboratory Ivo de Carneri

关键词: Trichuris trichiura;    Drug efficacy;    Drug safety;    Tanzania;    Ivermectin;    Moxidectin;    Albendazole;    Soil-transmitted helminthiasis;   

DOI  :  10.12688/gatesopenres.13299.2

学科分类：电子与电气工程

来源: American Journal Of Pharmtech Research

【 摘 要 】

Background: Infections with soil-transmitted helminths (STHs) predominantly affect impoverished populations in tropical environments. The periodic administration of single dose benzimidazoles (i.e., albendazole, mebendazole) to at-risk individuals in endemic regions is at the center of STH control strategies. Given the low efficacy of these drugs against trichuriasis, investigation of drug combinations including moxidectin and ivermectin has recently been initiated, yet the identification of the best treatment option requires more research. We present the protocol for a trial investigating the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole against Trichuris trichiura. Methods: We will conduct a randomized controlled trial enrolling 540 T. trichiura-infected adolescents aged 12-19 years on Pemba Island (Tanzania). The trial will be open-label with blinded outcome assessors. The primary objective is to demonstrate non-inferiority of orally co-administered single-dose moxidectin (8 mg)/albendazole (400 mg) compared to orally co-administered single-dose ivermectin (200 µg/kg)/albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment. Secondary objectives include the assessment of the drug combinations’ superiority compared to their respective monotherapies, of the cure rates (CRs) against T. trichiura, and the safety and tolerability of all treatments, as well as CRs and ERRs against concomitant STH infections ( Ascaris lumbricoides and hookworm). Potential effects of the treatment regimens on follow-up prevalences of STH at 5-6 weeks and 3 months post-treatment and pharmacokinetic/  pharmacodynamic parameters will also be assessed. Conclusions: Results from this trial will help to inform decision- and policymakers on which anthelminthic combination therapy might improve existing deworming programs and provide a valuable adjunct tool for interrupting STH transmission.

【 授权许可】

CC BY