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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

• Male or female children and adults

• Residents in the villages selected for MDA treatment

Locations
Other Locations
Angola
Villages in Andulo and Nharea Municipalities
RECRUITING
Andulo
Contact Information
Primary
Susana V Nery, PhD
snery@kirby.unsw.edu.au
+61467076047
Backup
Marta S Palmeirim, PhD
mpalmeirim@kirby.unsw.edu.au
+351916563622
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 52000
Treatments
Experimental: Moxidectin
Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year
Active_comparator: 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
Sponsors
Collaborators: Emory University, Murdoch Childrens Research Institute, World Health Organization, Swiss Tropical & Public Health Institute, La Trobe University, Ministry of Health, Angola, Erasmus Medical Center, University of Melbourne, University of Ottawa, The Mentor Initiative, Center for Research on Filariasis and Other Tropical Diseases, Cameroon, Medicines Development for Global Health, The END Fund
Leads: Kirby Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials