Phase III Clinical Trial to Evaluate Ivermectin in the Reduction of Mansonella ozzardi infection in the Brazilian Amazon

Sergio de Almeida Basano Secretaria de Saúde do Estado de Rondônia, Porto Velho, Brazil;
Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil;
Universidade Federal de São João Del Rei, Campus Centro Oeste, Divinópolis, Brazil;

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Juliana de Souza Almeida Aranha Camargo Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil;

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Gilberto Fontes Universidade Federal de São João Del Rei, Campus Centro Oeste, Divinópolis, Brazil;
Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil;

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Antonieta Relvas Pereira Universidade Federal de São João Del Rei, Campus Centro Oeste, Divinópolis, Brazil;

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Jansen Fernandes Medeiros Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil;
Fiocruz-Rondônia, Fundação Oswaldo Cruz, Porto Velho, Brazil;

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Mayara Costa de Oliveira Laudisse Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil;

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Ricardo de Godoi Mattos Ferreira Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil;
Fiocruz-Rondônia, Fundação Oswaldo Cruz, Porto Velho, Brazil;

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Luís Marcelo Aranha Camargo Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil;
Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil;
Instituto de Ciências Biomédicas 5 (ICB5 USP), Universidade de São Paulo, Monte Negro, Brazil;
Centro de Pesquisas em Medicina Tropical de Rondônia/SESAU, Porto Velho, Brazil

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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 Lábrea, 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.

Author Notes

Address correspondence to Luís Marcelo Aranha Camargo, Departamento de Parasitologia, Instituto de Ciências Biomédicas 5, Rua Francisco Prestes 1234, Monte Negro, Rondônia, CEP 76.888-000, Brazil. E-mail: spider@icbusp.org

Financial support: This study was supported by the University of São Paulo (USP) and Oswaldo Cruz Foundation–Fiocruz/Rondônia.

Authors’ addresses: Sergio de Almeida Basano, Secretaria de Saúde do Estado de Rondônia, Porto Velho, Brazil, and Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil, E-mail: sergio@icbusp.org. Juliana de Souza Almeida Aranha Camargo and Mayara Costa de Oliveira Laudisse, Centro Universitário São Lucas, Porto Velho, Brazil, E-mails: juliana@icbusp.org and mayaralaudisse@icloud.com. Gilberto Fontes, Universidade Federal de São João Del Rei, Divinópolis, Brazil, and Ins6tituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil, E-mail: gilberto.fontes@pq.cnpq.br. Antonieta Relvas Pereira, Universidade Federal de São João Del Rei, Minas Gerais, Brazil, E-mail: antonietarp@hotmail.com. Jansen Fernandes Medeiros and Ricardo de Godoi Mattos Ferreira, Fundação Oswaldo Cruz, Fiocruz-Rondônia, Porto Velho, Brazil, and Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil, E-mails: jmedeiro@gmail.com and ricardogodoi@fiocruz.br. Luís Marcelo Aranha Camargo, Departamento de Medicina, Centro Universitário São Lucas, Porto Velho, Brazil, Instituto de Ciências Biomédicas 5 (ICB5 USP), Universidade de São Paulo, Monte Negro, Brazil, Instituto Nacional de Epidemiologia na Amazônia Ocidental, Porto Velho, Brazil, and Centro de Pesquisas em Medicina Tropical de Rondônia/SESAU, Porto Velho, Brazil, E-mail: spider@icbusp.org.

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