Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moxidectin, Ivermectin.
- Who it may be relevant to
- Registry conditions: Onchocerciasis, Ascaris Lumbricoides Infection, Trichuris Trichiura; Infection, Hookworm Infections. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Angola
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial
Overview
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
- Drug Moxidectin
2 mg tablets - Drug Ivermectin
3 mg tablets
Primary outcome measures
- Prevalence of Onchocerca volvulus microfilariae [Time frame: 36 months after the first intervention]
Secondary outcome measures (12)
- Prevalence of O. volvulus microfilaria/mg skin [Time frame: 12, 24 and 36 months after the first intervention]
- Microfilariae density (mean, median) [Time frame: 12, 24 and 36 months after the first intervention]
- Prevalence of nodules [Time frame: 12, 24 and 36 months after the first intervention]
- Prevalence of onchocerciasis skin disease [Time frame: 12, 24 and 36 months after the first intervention]
- Proportion of black flies with infective O. volvulus larvae [Time frame: 12, 24 and 36 months after the first intervention]
- Prevalence of anti-Ov-16 [Time frame: 12, 24 and 36 months after the first intervention]
- Prevalence of Ascaris lumbricoides [Time frame: 12, 24 and 36 months after the first intervention]
- Intensity of Ascaris lumbricoides infection [Time frame: 12, 24 and 36 months after the first intervention]
- Prevalence of Trichuris trichiura [Time frame: 12, 24 and 36 months after the first intervention]
- Intensity of Trichuris trichiura infection [Time frame: Baseline and 12, 24 and 36 months after the first intervention]
- Prevalence of hookworm [Time frame: 12, 24 and 36 months after the first intervention]
- Intensity of hookworm infection [Time frame: 12, 24 and 36 months after the first intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Angola · 1 center
- Villages in Andulo and Nharea Municipalities — Andulo
Identifiers
NCT: NCT07145736 · KirbyI