NCT07145736 Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
| NCT ID | NCT07145736 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kirby Institute |
| Condition | Onchocerciasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 52,000 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 52,000 participants in total. It began in 2025-08-04 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Susana V Nery, PhD
PRINCIPAL INVESTIGATOR
Kirby Institute, University of New South Wales, Australia
Frequently Asked Questions
Who can join the NCT07145736 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Onchocerciasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07145736 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07145736 currently recruiting?
Yes, NCT07145736 is actively recruiting participants. Contact the research team at snery@kirby.unsw.edu.au for enrollment information.
Where is the NCT07145736 trial being conducted?
This trial is being conducted at Andulo, Angola.
Who is sponsoring the NCT07145736 clinical trial?
NCT07145736 is sponsored by Kirby Institute. The principal investigator is Susana V Nery, PhD at Kirby Institute, University of New South Wales, Australia. The trial plans to enroll 52,000 participants.