Moxidectin versus ivermectin mass treatment to control river blindness and other common infections in Angolan villages

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

This project will test whether giving moxidectin or ivermectin to whole villages better lowers river blindness and other common infections in people living in selected Angolan communities.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 52000 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: Kirby Institute (other gov)
• Locations: 1 site (Andulo, Bíe Province)
• Trial ID: NCT07145736 on ClinicalTrials.gov

What this trial studies

This Phase 4, community-level comparison randomizes villages in Andulo and Nharea municipalities (Bié Province, Angola) to receive mass drug administration (MDA) with either moxidectin or ivermectin. Researchers will measure changes in the prevalence and intensity of onchocerciasis (river blindness), soil-transmitted helminths (Ascaris, Trichuris, hookworm), and scabies over time. Parasite genetic testing will be used to estimate impacts on onchocerciasis transmission within communities. Age, pregnancy, breastfeeding, and allergy-based eligibility rules apply and safety and population-level effects will be monitored during follow-up.

Who should consider this trial

Good fit: Ideal candidates are residents of the selected Angolan villages who meet the local MDA age, height, pregnancy, and breastfeeding eligibility rules and who do not have known allergies to ivermectin or moxidectin.

Not a fit: People who are pregnant, excluded young children (per arm-specific age/height rules), breastfeeding women excluded by arm rules, those allergic to the drugs, or those who refuse treatment are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If moxidectin performs better at the community level, using it in MDA could lower how common and how heavy infections are and could reduce transmission of river blindness.

How similar studies have performed: Individual randomized trials have shown moxidectin lowers onchocerciasis microfilariae for longer than ivermectin, but comparisons of these drugs as large-scale community MDA are limited.

Eligibility criteria

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

Where this trial is running

Andulo, Bíe Province

• Villages in Andulo and Nharea Municipalities — Andulo, Bíe Province, Angola (RECRUITING)

Study contacts

• Principal investigator: Susana V Nery, PhD — Kirby Institute, University of New South Wales, Australia
• Study coordinator: Susana V Nery, PhD

Conditions: Onchocerciasis, Ascaris Lumbricoides Infection, Trichuris Trichiura, Infection, Hookworm Infections, Scabies