Villages in Andulo and Nharea Municipalities
Andulo, Bíe Province, Angola
Location status: Recruiting
NCT Number: NCT07145736
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.
Interested in participating?
Request Info5 year and older
All sexes
Interventional
Phase 4
Andulo, Bíe Province, Angola
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 mg tablets
3 mg tablets
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
Time frame: 12, 24 and 36 months after the first intervention
Time frame: 12, 24 and 36 months after the first intervention
Time frame: 12, 24 and 36 months after the first intervention
Time frame: 12, 24 and 36 months after the first intervention
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
Time frame: 12, 24 and 36 months after the first intervention
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: Baseline and 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Contact information is provided by the study sponsor or research team.
Marta S Palmeirim, PhD
CONTACT
Susana V Nery, PhD
CONTACT
Kirby Institute
Other Gov
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial
Acronym: EKAIO
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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