Phase III clinical trial to evaluate ivermectin in the reduction of Mansonella ozzardi infection in the Brazilian Amazon
| Autor: | Juliana de Souza Almeida Aranha Camargo, Mayara Costa de Oliveira Laudisse, Ricardo de Godoi Mattos Ferreira, Jansen Fernandes Medeiros, Antonieta Relvas Pereira, Gilberto Fontes, Luís Marcelo Aranha Camargo, Sergio de Almeida Basano |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
VETORES medicine.medical_specialty 030106 microbiology 030231 tropical medicine Placebo law.invention 03 medical and health sciences 0302 clinical medicine Mansonella Ozzardi Infection Ivermectin Randomized controlled trial law Virology Internal medicine parasitic diseases Medicine Adverse effect biology business.industry Mansonelliasis biology.organism_classification medicine.disease Clinical trial Infectious Diseases Parasitology Mansonella ozzardi business medicine.drug |
| Zdroj: | Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| Popis: | The treatment of mansonelliasis is still a challenge because there are few clinical trials for the treatment of the disease. This double-blind, randomized, placebo-controlled study (phase III clinical trial) was conducted to evaluate the effectiveness of a single oral dose of ivermectin (0.15 mg/kg) in the reduction of the Mansonella ozzardi microfilaraemia and the occurrence of adverse effects in infected people compared with the control group treated with placebo. A total of 49 microfilaraemic patients were randomly selected from the municipality of Labrea, State of Amazonas, in the Brazilian Amazon. Among them, 40 patients have concluded the study, 19 treated with ivermectin and 21 treated with placebo. In the first and third days after the treatment, all the patients were clinically evaluated, and the diagnostic and quantification of blood microfilariae through blood filtration in polycarbonate membranes was performed. A significant reduction of the microfilaraemia (99.9%) was observed in the patients who received ivermectin. Slight changes in laboratory test results, without clinical importance, were seen in treated and control groups. Our results suggest that ivermectin is effective and safe for the treatment of infections caused by M. ozzardi. |
| Databáze: | OpenAIRE |
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