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| Name | Class |
|---|---|
| Emory University | OTHER |
| La Trobe University | OTHER |
| Murdoch Childrens Research Institute | OTHER |
| Medicines Development for Global Health |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidectin | Experimental | Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin | Drug | 2 mg tablets |
| |
| Ivermectin |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susana V Nery, PhD | Contact | +61467076047 | snery@kirby.unsw.edu.au | |
| Marta S Palmeirim, PhD | Contact | +351916563622 | mpalmeirim@kirby.unsw.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Susana V Nery, PhD | Kirby Institute, University of New South Wales, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Villages in Andulo and Nharea Municipalities | Recruiting | Andulo | BÃe Province | Angola |
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| OTHER |
| University of Melbourne | OTHER |
| Swiss Tropical & Public Health Institute | OTHER |
| University of Ottawa | OTHER |
| The Mentor Initiative | OTHER |
| Erasmus Medical Center | OTHER |
| Ministry of Health, Angola | UNKNOWN |
| The END Fund | UNKNOWN |
| Center for Research on Filariasis and Other Tropical Diseases, Cameroon | OTHER |
| World Health Organization | OTHER |
Clusters of villages are assigned to either ivermectin or moxidectin in parallel for the duration of the study.
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| Drug |
3 mg tablets |
|
| 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 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 |
| Prevalence of scabies/impetigo | 12, 24 and 36 months after the first intervention |
| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| D014257 | Trichuriasis |
| D006725 | Hookworm Infections |
| D012532 | Scabies |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D017206 | Strongylida Infections |
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
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| ID | Term |
|---|---|
| C027837 | moxidectin |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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