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Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

NCT04848688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2024-01-25

Study results available
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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.

Conditions

  • Strongyloides Stercoralis Infection

Interventions

DRUG

Moxidectin 2 mg

Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.

DRUG

Ivermectin 3 mg

Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.

DRUG

Placebo

Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin

Sponsors & Collaborators

  • National Centre for Parasitology, Entomology and Malaria Control, Cambodia

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Principal Investigators

  • Jennifer Keiser, Prof. Dr · STPH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-05
Primary Completion
2022-07-17
Completion
2022-07-17

Countries

  • Cambodia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848688 on ClinicalTrials.gov