CompletedPhase 3

Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

Cambodia332 participantsStarted 2022-02-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (18-65 years) * Infected with S. stercoralis (positive) * Absence of major systemic illnesses * Written informed consent Exclusion Criteria: * Any abnormal medical conditions or chronic disease * Negative diagnostic result for S. stercoralis * No written informed consent by the individual. * Pregnant and lactating women. * Recent use of an anthelmintic drug (within past 4 weeks) * Attending other clinical trials during the study * Known allergy to study medications (i.e. moxidectin, ivermectin) * Currently taking medications with known interaction (i.e. for warfarin)

What they're measuring

Cure Rate Against Strongyloides Stercoralis

Timeframe: 14-21 days after treatment

Trial details

NCT IDNCT04848688

SponsorJennifer Keiser

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-17

Results submitted2023-04-24

View on ClinicalTrials.gov More Strongyloides Stercoralis Infection trials