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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5+
SponsorKirby Institute

About this trial

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 criteria

Qualifiers

Male or female children and adults

Residents in the villages selected for MDA treatment

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Moxidectin
  • Ivermectin

Treatment groups

52,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kirby Institute

Lead sponsor

Emory University

Collaborator

La Trobe University

Collaborator

Murdoch Childrens Research Institute

Collaborator

Medicines Development for Global Health

Collaborator

University of Melbourne

Collaborator

Swiss Tropical & Public Health Institute

Collaborator

University of Ottawa

Collaborator

The Mentor Initiative

Collaborator

Erasmus Medical Center

Collaborator

Ministry of Health, Angola

Collaborator

The END Fund

Collaborator

Center for Research on Filariasis and Other Tropical Diseases, Cameroon

Collaborator

World Health Organization

Collaborator