Phase 3 N=332 Randomized Quadruple-blind Treatment

Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

Strongyloides Stercoralis Infection

Bottom Line

View on ClinicalTrials.gov: NCT04848688 ↗

Enrolled (actual)

332

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Cure Rate Against Strongyloides Stercoralis — 94.8; 99.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Moxidectin 2 mg (Drug); Ivermectin 3 mg (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jennifer Keiser
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Cure Rate Against Strongyloides Stercoralis	94.8; 99.4	—
SECONDARY Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis	98.8; 100	—
SECONDARY CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides	—	—
SECONDARY CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura	—	—
SECONDARY CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm	82.0; 81.0	—
SECONDARY Number of Participants Reporting Adverse Events	4; 10; 2; 4; 3; 0	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04848688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.