OnchocerciasisPhase 4EKAIONCT07145736
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
A Phase 4 study testing Moxidectin and Ivermectin in people with Onchocerciasis and Ascaris Lumbricoides Infection, run by Kirby Institute at 1 site in Angola.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onchocerciasis, Ascaris Lumbricoides Infection, Trichuris Trichiura; Infection
- What is being tested?
- Moxidectin and Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52,000 participants
- Where
- 1 siteAngola
- Study dates
- 4 Aug 2025to 30 Jun 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female children and adults
- Residents in the villages selected for MDA treatment
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angola1 site, 1 recruiting
- Recruiting
Villages in Andulo and Nharea Municipalities
Andulo, Bíe Province
Marta Palmeirim, PhD, +351 916 563 622, mpalmeirim@kirby.unsw.edu.au
About this study
Official title: Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised 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:
Read more
- 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.
- Conditions
- Onchocerciasis, Ascaris Lumbricoides Infection, Trichuris Trichiura; Infection, Hookworm Infections, Scabies
- Being tested
- Moxidectin, Ivermectin
- Medical subject headings
- Onchocerciasis, Trichuriasis, Hookworm Infections, Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxidectinDrug
2 mg tablets
IvermectinDrug
3 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Moxidectin | Experimental | Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year Receives: Drug: Moxidectin |
| Ivermectin | Active comparator | 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 Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Onchocerca volvulus microfilariae
Prevalence of O. volvulus microfilariae at 36 months in skin snips, the marker most likely to show change in the shorter term as demonstrated by the therapeutic trials
Measured: 36 months after the first intervention
Secondary outcomes (15)
Prevalence of O. volvulus microfilaria/mg skin
Measured: 12, 24 and 36 months after the first intervention
Microfilariae density (mean, median)
Measured: 12, 24 and 36 months after the first intervention
Prevalence of nodules
Measured: 12, 24 and 36 months after the first intervention
Prevalence of onchocerciasis skin disease
Measured: 12, 24 and 36 months after the first intervention
Proportion of black flies with infective O. volvulus larvae
Infection assessed based on all 3 are markers recommended by WHO to define population-level elimination
Measured: 12, 24 and 36 months after the first intervention
Prevalence of anti-Ov-16
Measured: 12, 24 and 36 months after the first intervention
Prevalence of Ascaris lumbricoides
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Intensity of Ascaris lumbricoides infection
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Prevalence of Trichuris trichiura
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Intensity of Trichuris trichiura infection
Measured through qPCR
Measured: Baseline and 12, 24 and 36 months after the first intervention
Prevalence of hookworm
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Intensity of hookworm infection
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Prevalence of Strongyloides stercoralis
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Intensity of Strongyloides stercoralis infection
Measured through qPCR
Measured: 12, 24 and 36 months after the first intervention
Prevalence of scabies/impetigo
Measured: 12, 24 and 36 months after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start4 Aug 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnchocerciasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clusters of villages are assigned to either ivermectin or moxidectin in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Emory University, La Trobe University, Murdoch Childrens Research Institute, Medicines Development for Global Health, University of Melbourne, Swiss Tropical & Public Health Institute, University of Ottawa, The Mentor Initiative, Erasmus Medical Center, Ministry of Health, Angola, The END Fund, Center for Research on Filariasis and Other Tropical Diseases, Cameroon, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Susana V Nery, PhD, Principal investigator, Kirby Institute, University of New South Wales, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145736
- Sponsor's protocol ID
- KirbyI
- Acronym
- EKAIO
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided