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NCT Number: NCT07145736

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxidectin

Drug

2 mg tablets

Ivermectin

Drug

3 mg tablets

Primary outcomes

  1. Prevalence of Onchocerca volvulus microfilariae

    Time frame: 36 months after the first intervention

    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

Secondary outcomes

  1. Prevalence of O. volvulus microfilaria/mg skin

    Time frame: 12, 24 and 36 months after the first intervention

  2. Microfilariae density (mean, median)

    Time frame: 12, 24 and 36 months after the first intervention

  3. Prevalence of nodules

    Time frame: 12, 24 and 36 months after the first intervention

  4. Prevalence of onchocerciasis skin disease

    Time frame: 12, 24 and 36 months after the first intervention

  5. Proportion of black flies with infective O. volvulus larvae

    Time frame: 12, 24 and 36 months after the first intervention

    Infection assessed based on all 3 are markers recommended by WHO to define population-level elimination

  6. Prevalence of anti-Ov-16

    Time frame: 12, 24 and 36 months after the first intervention

  7. Prevalence of Ascaris lumbricoides

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  8. Intensity of Ascaris lumbricoides infection

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  9. Prevalence of Trichuris trichiura

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  10. Intensity of Trichuris trichiura infection

    Time frame: Baseline and 12, 24 and 36 months after the first intervention

    Measured through qPCR

  11. Prevalence of hookworm

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  12. Intensity of hookworm infection

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  13. Prevalence of Strongyloides stercoralis

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  14. Intensity of Strongyloides stercoralis infection

    Time frame: 12, 24 and 36 months after the first intervention

    Measured through qPCR

  15. Prevalence of scabies/impetigo

    Time frame: 12, 24 and 36 months after the first intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Marta S Palmeirim, PhD

CONTACT

[email protected]

+351916563622

Susana V Nery, PhD

CONTACT

[email protected]

+61467076047

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Center for Research on Filariasis and Other Tropical Diseases, Cameroon
  • Emory University
  • Erasmus Medical Center
  • La Trobe University
  • Medicines Development for Global Health
  • Ministry of Health, Angola
  • Murdoch Childrens Research Institute
  • Swiss Tropical & Public Health Institute
  • The END Fund
  • The Mentor Initiative
  • University of Melbourne
  • University of Ottawa
  • World Health Organization

Registry information

Official study title

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

Acronym: EKAIO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 28, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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