Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

52000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2029-06-30

Brief Summary

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This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies.

The trial aims to answer the following key questions:

* How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community?
* Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies?
* Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection?
* How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling?
* How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin?

The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.

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Detailed Description

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Conditions

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Onchocerciasis Ascaris Lumbricoides Infection Trichuris Trichiura; Infection Hookworm Infections Scabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clusters of villages are assigned to either ivermectin or moxidectin in parallel for the duration of the study.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Moxidectin

Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

2 mg tablets

Ivermectin

Single oral dose of ivermectin treatment with approximately 150 µg/kg determined based on height (between 1 and 4 tablets of 3 mg of ivermectin), once per year

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

3 mg tablets

Interventions

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Moxidectin

2 mg tablets

Intervention Type DRUG

Ivermectin

3 mg tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female children and adults
* Residents in the villages selected for MDA treatment

Exclusion Criteria

* Arm 1 (ivermectin): children under the age of 5 and/or under 90 cm of height
* Arm 2 (moxidectin): children under the age of 12 years (who will receive ivermectin if they are at least 90 cm in height/5 years of age and above).
* Arm 1 (ivermectin): Women breast-feeding babies under 45 days of age
* Arm 2 (moxidectin): All breastfeeding women (who will be offered ivermectin if their infants is at least 45 days old)
* Know allergy to ivermectin or moxidectin
* Attending other clinical trials during the study
* Pregnant
* Arm 2 (moxidectin): Women planning to become pregnant in the 3 months post-treatment
* Refusal to receive one or both study drugs, i.e. participants in villages allocated to receive moxidectin who refuse to receive moxidectin will be given the option to receive ivermectin; if they refuse to receive both drugs they will be excluded from the MDA altogether
* Has an illness that makes them too sick or weak to get out of bed
* Currently hospitalized

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes