Ascaris Lumbricoides Infection, Hookworm Infections, Onchocerciasis, Scabies, Trichuris Trichiura; Infection
Conditions
Brief 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. 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.
Interventions
DRUGMoxidectin
2 mg tablets
DRUGIvermectin
3 mg tablets
Sponsors
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
Kirby Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Clusters of villages are assigned to either ivermectin or moxidectin in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Onchocerca volvulus microfilariae | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of black flies with infective O. volvulus larvae | 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 |
| Prevalence of anti-Ov-16 | 12, 24 and 36 months after the first intervention | — |
| Prevalence of Ascaris lumbricoides | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| 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 | — |
| Intensity of Ascaris lumbricoides infection | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Prevalence of onchocerciasis skin disease | 12, 24 and 36 months after the first intervention | — |
| Intensity of Trichuris trichiura infection | Baseline and 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Prevalence of hookworm | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Intensity of hookworm infection | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Prevalence of Strongyloides stercoralis | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Intensity of Strongyloides stercoralis infection | 12, 24 and 36 months after the first intervention | Measured through qPCR |
| Prevalence of scabies/impetigo | 12, 24 and 36 months after the first intervention | — |
| Prevalence of Trichuris trichiura | 12, 24 and 36 months after the first intervention | Measured through qPCR |
Countries
Angola
Contacts
Primary ContactSusana V Nery, PhD
Backup ContactMarta S Palmeirim, PhD
Outcome results
None listed