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

NCT04056325 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2024-12-09

Study results available
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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.

Conditions

  • Strongyloides Stercoralis Infection

Interventions

DRUG

Moxidectin

Monotherapy, oral administration, single dose, fixed dose

DRUG

Ivermectin

Monotherapy, oral administration, single dose, weight dependent

DRUG

Placebo oral tablet

Monotherapy, oral administration, single dose, matching number of tablets

Sponsors & Collaborators

  • National Institute of Public Health, Vientiane, Laos

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Principal Investigators

  • Jennifer Keiser, Prof. Dr. · Swiss TPH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Laos

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056325 on ClinicalTrials.gov