CompletedPhase 2/3

Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

Laos617 participantsStarted 2019-11-27

Plain-language summary

This study is a phase 2, blinded and randomized clinical trial. The phase 2a trial is single blinded and conducted in Lao, while the phase 2b trial is double-blinded and conducted in Lao and Cambodia. The study aims at providing evidence on effective doses and safety of moxidectin in adults against infection with S. stercoralis in Laos (trial 2a) and efficacy and safety of moxidectin compared to ivermectin in adults against infection with S. stercoralis in Laos and Cambodia (trial 2b). The efficacy of the treatment will be assessed by collecting three stool samples once pre-treatment and once 21 days post-treatment. The stool samples will be analyzed by a quantitative Baermann assay.

Who can participate

Age range18 Years – 60 Years

SexALL

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

Inclusion Criteria: * Adults (≥ 18 years) infected with S. stercoralis * Absence of major systemic illnesses * Written informed consent signed by individual Exclusion Criteria: * Any abnormal medical conditions or chronic disease * Negative diagnostic result for S. stercoralis * No written informed consent by individual. * Pregnant and lactating women. * Recent use of 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

Observed Cure Rate Against Strongyloides Stercoralis

Timeframe: Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

Trial details

NCT IDNCT04056325

SponsorJennifer Keiser

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-30

Results submitted2023-04-23