Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial
| Autor: | George Olipoh, Amos Nyathirombo, Mupenzi Mumbere, Safari L Masembe, Annette C. Kuesel, N. O. Opoku, Fatorma Bolay, Sampson Asare, Didier K. Bakajika, Kpehe M Bolay, Kambale Kataliko, Jemmah P Larbelee, Simon K. Attah, Hayford Howard, Germain L Mambandu, Maurice M. Nigo, Eric M Kanza, Christine M Halleux, Kambale Kasonia, Mawolo Kpawor, Michel Vaillant |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Male Endemic Diseases Blindness Onchocerciasis Ghana Parasite Load law.invention chemistry.chemical_compound 0302 clinical medicine Ivermectin Randomized controlled trial law Medicine Microfilariae Lymphatic filariasis Skin Anthelmintics education.field_of_study biology General Medicine Moxidectin Democratic Republic of the Congo Female Macrolides Loa loa medicine.drug medicine.medical_specialty Adolescent 030231 tropical medicine Population Article 03 medical and health sciences Double-Blind Method Onchocerciasis Ocular Internal medicine parasitic diseases Animals Humans education business.industry biology.organism_classification medicine.disease Liberia Onchocerca volvulus 030104 developmental biology chemistry business |
| Zdroj: | Lancet (London, England) |
| ISSN: | 1474-547X |
| Popis: | Summary Background The morbidity and socioeconomic effects of onchocerciasis, a parasitic disease that is primarily endemic in sub-Saharan Africa, have motivated large morbidity and transmission control programmes. Annual community-directed ivermectin treatment has substantially reduced prevalence. Elimination requires intensified efforts, including more efficacious treatments. We compared parasitological efficacy and safety of moxidectin and ivermectin. Methods This double-blind, parallel group, superiority trial was done in four sites in Ghana, Liberia, and the Democratic Republic of the Congo. We enrolled participants (aged ≥12 years) with at least 10 Onchocerca volvulus microfilariae per mg skin who were not co-infected with Loa loa or lymphatic filariasis microfilaraemic. Participants were randomly allocated, stratified by sex and level of infection, to receive a single oral dose of 8 mg moxidectin or 150 μg/kg ivermectin as overencapsulated oral tablets. The primary efficacy outcome was skin microfilariae density 12 months post treatment. We used a mixed-effects model to test the hypothesis that the primary efficacy outcome in the moxidectin group was 50% or less than that in the ivermectin group. The primary efficacy analysis population were all participants who received the study drug and completed 12-month follow-up (modified intention to treat). This study is registered with ClinicalTrials.gov, number NCT00790998. Findings Between April 22, 2009, and Jan 23, 2011, we enrolled and allocated 998 participants to moxidectin and 501 participants to ivermectin. 978 received moxidectin and 494 ivermectin, of which 947 and 480 were included in primary efficacy outcome analyses. At 12 months, skin microfilarial density (microfilariae per mg of skin) was lower in the moxidectin group (adjusted geometric mean 0·6 [95% CI 0·3–1·0]) than in the ivermectin group (4·5 [3·5–5·9]; difference 3·9 [3·2–4·9], p |
| Databáze: | OpenAIRE |
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