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

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Keiser
• Collaborator: National Centre for Parasitology, Entomology and Malaria Control, Cambodia
• Treatments: Ivermectin; Milbemycin; Moxidectin

Criteria

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)