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 range

18 Years – 65 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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