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

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Keiser
• Collaborators: National Centre for Parasitology, Entomology and Malaria Control, Cambodia; National Institute of Public Health, Vientiane, Laos
• Treatments: Ivermectin; Milbemycin; Moxidectin

Criteria

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)