Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

Phase 3 Completed 332 enrolled Jennifer Keiser National Centre for Parasitology, Entomology and Malaria Control, Cambodia · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based on the outcome of NCT04056325 part A. The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia. It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The efficacy of the treatment will be assessed by collecting three stool samples once per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a quantitative duplicate Baermann assay.

Timeline

Start: 2022-02-05
Primary completion: 2022-07-17
Completion: 2022-07-17

Outcome

Met primary endpoint

paper Moxidectin was non-inferior to ivermectin in terms of efficacy in the treatment of strongyloidiasis. PMID 37949090 ↗

Publications

Sprecher VP, Hofmann D, Savathdy V, Xayavong P, Norkhankhame C, Huy R, Khieu V, Sayasone S, Hattendorf J, Keiser J. Efficacy and safety of moxidectin compared with ivermectin against Strongyloides stercoralis infection in adults in Laos and Cambodia: a randomised, double-blind, non-inferiority, phase 2b/3 trial. Lancet Infect Dis. 2024 Feb;24(2):196-205. doi: 10.1016/S1473-3099(23)00507-8. Epub 2023 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	200 ug/kg	Oral
Subject	Moxidectin	Other / unclassified	8 mg	Oral