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

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:

• 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.

Study Overview

• Status: Recruiting
• Conditions: Onchocerciasis; Hookworm Infections; Scabies; Ascaris Lumbricoides Infection; Trichuris Trichiura; Infection
• Intervention / Treatment: Drug: Moxidectin; Drug: Ivermectin

• Study Type: Interventional
• Enrollment (Estimated): 52000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Susana V Nery, PhD; Phone Number: +61467076047; Email: snery@kirby.unsw.edu.au
• Study Contact Backup: Name: Marta S Palmeirim, PhD; Phone Number: +351916563622; Email: mpalmeirim@kirby.unsw.edu.au

Study Locations

• Angola
  • Bíe Province
    • Andulo, Bíe Province, Angola
      • Recruiting
      • Villages in Andulo and Nharea Municipalities
      • Contact: Marta Palmeirim, PhD; Phone Number: +351 916 563 622; Email: mpalmeirim@kirby.unsw.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxidectin; Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year	Drug: Moxidectin; 2 mg tablets
Active Comparator: Ivermectin; 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	Drug: Ivermectin; 3 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months after the first intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of O. volvulus microfilaria/mg skin		12, 24 and 36 months after the first intervention
Microfilariae density (mean, median)		12, 24 and 36 months after the first intervention
Prevalence of nodules		12, 24 and 36 months after the first intervention
Prevalence of onchocerciasis skin disease		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	12, 24 and 36 months after the first intervention
Prevalence of anti-Ov-16		12, 24 and 36 months after the first intervention
Prevalence of scabies/impetigo		12, 24 and 36 months after the first intervention
Prevalence of Ascaris lumbricoides	Measured through qPCR	12, 24 and 36 months after the first intervention
Intensity of Ascaris lumbricoides infection	Measured through qPCR	12, 24 and 36 months after the first intervention
Prevalence of Trichuris trichiura	Measured through qPCR	12, 24 and 36 months after the first intervention
Intensity of Trichuris trichiura infection	Measured through qPCR	Baseline and 12, 24 and 36 months after the first intervention
Prevalence of hookworm	Measured through qPCR	12, 24 and 36 months after the first intervention
Intensity of hookworm infection	Measured through qPCR	12, 24 and 36 months after the first intervention
Prevalence of Strongyloides stercoralis	Measured through qPCR	12, 24 and 36 months after the first intervention
Intensity of Strongyloides stercoralis infection	Measured through qPCR	12, 24 and 36 months after the first intervention

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: Emory University; Erasmus Medical Center; University of Ottawa; World Health Organization; Swiss Tropical & Public Health Institute; Medicines Development for Global Health; Murdoch Childrens Research Institute; University of Melbourne; La Trobe University; Center for Research on Filariasis and Other Tropical Diseases, Cameroon; The Mentor Initiative; Ministry of Health, Angola; The END Fund
• Investigators: Principal Investigator: Susana V Nery, PhD, Kirby Institute, University of New South Wales, Australia

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Estimated): August 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Skin Diseases, Parasitic; Helminthiasis; Mite Infestations; Ectoparasitic Infestations; Enoplida Infections; Adenophorea Infections; Strongylida Infections; Filariasis; Skin and Connective Tissue Diseases; Onchocerciasis; Scabies; Trichuriasis; Hookworm Infections; Organic Chemicals; Macrolides; Lactones; Polyketides; Ivermectin; moxidectin
• Other Study ID Numbers: KirbyI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes