Actively Recruiting

Phase 4
Age: 5Years +
All Genders
Healthy Volunteers
ID07145736

Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial

Led by Kirby Institute · Updated on 2025-11-21

52000

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

K

Kirby Institute

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two treatments, ivermectin and moxidectin, to find out which is more effective at reducing onchocerciasis, also known as river blindness, through mass drug administration (MDA) in Angola. Both drugs are approved by the FDA for this disease. The study also examines how these treatments affect other common infections in the area, such as intestinal worms and scabies. It aims to understand their impact on reducing disease prevalence and transmission, and how communities respond to these treatments. The trial involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Moxidectin is given as a single oral dose of 8 mg (four 2 mg tablets), while ivermectin is dosed by height with between one and four 3 mg tablets per dose. Before each treatment round, researchers collect skin, stool, and blood samples from selected participants to monitor infection levels and other health indicators. Participants will be involved in yearly treatment rounds for four years, with regular sample collections before each treatment to assess infection prevalence and intensity. Researchers will also test blackflies that transmit the disease and conduct genetic tests on parasites to evaluate transmission changes. The main outcome is the presence of Onchocerca volvulus microfilariae 36 months after the first treatment, alongside various secondary measures of infection and disease signs. The study may continue monitoring through 2029 to guide future disease control policies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female children and adults
  • Residents in the villages selected for MDA treatment
Not Eligible

You will not qualify if you...

  • Children under 5 years old and/or under 90 cm tall for ivermectin group
  • Children under 12 years old for moxidectin group (these children may receive ivermectin if they meet height/age requirements)
  • Women breastfeeding babies under 45 days old for ivermectin group
  • All breastfeeding women for moxidectin group (may receive ivermectin if infant is at least 45 days old)
  • Known allergy to ivermectin or moxidectin
  • Participation in other clinical trials during the study
  • Pregnancy
  • Women planning pregnancy within 3 months after moxidectin treatment
  • Refusal to receive one or both study drugs
  • Illness causing inability to get out of bed
  • Current hospitalization

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Annual dosing for up to 3 years

Participants receive a single oral dose of either moxidectin or ivermectin once per year as part of mass drug administration.

1 dosing visit per year

Follow-up

Duration - Up to 36 months after the first intervention

Participants are monitored for prevalence and intensity of various infections and onchocerciasis-related conditions at multiple timepoints after treatment.

Visits at 12, 24, and 36 months post-treatment

Trial Site Locations

Total: 1 location

1

Villages in Andulo and Nharea Municipalities

Andulo, Bíe Province, Angola

Actively Recruiting

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Research Team

S

Susana V Nery, PhD

M

Marta S Palmeirim, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Frequently Asked Questions

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