At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Moxidectin in Comparison to Ivermectin Against Strongyloides Stercoralis Infection in Adults: a Randomized Controlled Non-inferiority Trial
In Brief
A Phase 3 clinical trial evaluating Moxidectin 2 mg, Ivermectin 3 mg, and 1 other intervention for Strongyloides Stercoralis Infection. Completed, enrolled 332 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.
Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin