Phase 3
Completed N=332
Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
Strongyloides Stercoralis Infection
Source: ClinicalTrials.gov NCT04848688 ↗
Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Cure Rate Against Strongyloides Stercoralis — 94.8; 99.4 percentage of participants
◆ Published Evidence
Emerging
16citations · ~8 / year
Efficacy and safety of moxidectin compared with ivermectin against Strongyloides stercoralis infection in adults in Laos and Cambodia: a randomised, double-blind, non-inferiority, phase 2b/3 trial.
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.
Linked Publications
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Efficacy and safety of moxidectin compared with ivermectin against Strongyloides stercoralis infection in adults in Laos and Cambodia: a randomised, double-blind, non-inferiority, phase 2b/3 trial.
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 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04848688) and the linked publication. 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. Informational only — not medical advice.