Phase 3
N=223
Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
Strongyloides Stercoralis Infection
Bottom Line
View on ClinicalTrials.gov: NCT04056325 ↗Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Observed Cure Rate Against Strongyloides Stercoralis — 73.3; 89.7; 84.4; 82.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxidectin (Drug); Ivermectin (Drug); Placebo oral tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Cure Rate Against Strongyloides Stercoralis |
73.3; 89.7; 84.4; 82.8; 96.6; 87.1 | — |
| SECONDARY Observed Larvae-reduction Rate (LRR) Against Strongyloides Stercoralis |
98.4; 99.4; 99.8; 97.8; 98.6; 98.5 | — |
| SECONDARY Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides |
0; 100; 100; 100; 0; 100 | — |
| SECONDARY Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura |
100; 100; 50; 33; 0; 0 | — |
| SECONDARY Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm |
0; 11; 14; 0; 10; 29 | — |
| SECONDARY Number of Participants Reporting Adverse Events |
1; 1; 1; 1; 2; 0 | — |
| SECONDARY Maximum Concentration (Cmax) of Moxidectin in Adults |
86.1 | — |
| SECONDARY Time to Reach Cmax (Tmax) of Moxidectin in Adults |
4 | — |
| SECONDARY Area Under the Curve (AUC) of Moxidectin in Adults |
5028 | — |
| SECONDARY Elimination Half Life (T1/2) of Moxidectin in Adults |
666 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04056325). 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.