Author | Lyra, Marcelo R. | |
Author | Oliveira, Liliane F. A. | |
Author | Schubach, Armando O. | |
Author | Sampaio, Raimunda N. R. | |
Author | Rodrigues, Bruna C. | |
Author | Hueb, Marcia | |
Author | Cota, Gláucia | |
Author | Silva, Rosiana E. | |
Author | Francesconi, Fabio | |
Author | Pompilio, Maurício A. | |
Author | França, Adriana O. | |
Author | Amato, Valdir S. | |
Author | Souza, Regina M. | |
Author | Oliveira, Raquel V. C. | |
Author | Valete, Cláudia M. | |
Author | Pimentel, Maria I. F. | |
Access date | 2023-12-26T23:45:20Z | |
Available date | 2023-12-26T23:45:20Z | |
Document date | 2023 | |
Citation | LYRA, Marcelo R. et al. A Randomized, Controlled, Noninferiority, Multicenter Trial of Systemic vs Intralesional Treatment With Meglumine Antimoniate for Cutaneous Leishmaniasis in Brazil. Clinical Infectious Diseases, v. 77, n. 4, p. 574-582, Aug. 2023. | en_US |
ISSN | 1058-4838 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/61996 | |
Language | eng | en_US |
Publisher | Oxford University Press | en_US |
Rights | restricted access | en_US |
Title | A Randomized, Controlled, Noninferiority, Multicenter Trial of Systemic vs Intralesional Treatment With Meglumine Antimoniate for Cutaneous Leishmaniasis in Brazil | en_US |
Type | Article | en_US |
DOI | 10.1093/cid/ciad253 | |
Abstract | Background: Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL). Uncontrolled studies suggest that intralesional MA (IL-MA) may be noninferior and safer than systemic MA (S-MA). Methods: Multicenter, randomized, controlled, open-label, phase 3 clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared with S-MA (10-20 mg Sb5+/kg/day, 20 days) for CL, with noninferiority margin of 20%. Primary and secondary outcomes were definitive cure at day 180 and epithelialization rate at day 90 of treatment, respectively. A 2-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AEs) were monitored according to the Division of AIDS AE grading system. Results: We evaluated 135 patients. The cure rates (95% confidence interval) for IL-MA and S-MA treatment were, respectively, 82.8% (70.5-91.4) and 67.8% (53.3-78.3) per protocol (PP) and 70.6% (58.3-81.0) and 59.7% (47.0-71.5) per intention to treat (ITT). The epithelialization rates of the IL-MA and S-MA treatment were, respectively, 79.3% (66.6-88 + 8) and 71.2% (57.9-82.2) PP and 69.1% (55.2-78.5) and 64.2% (50.0-74.2) ITT. AEs in the IL-MA and S-MA groups were, respectively, clinical, 45.6% and 80.6%; laboratory, 26.5% and 73.1%; and electrocardiogram, 8.8% and 25.4%. Ten participants in the S-MA group and 1 in the IL-MA group were discontinued due to severe or persistent AEs. Conclusions: IL-MA provides a similar cure rate and results in less toxicity compared with S-MA and may be used as first-line therapy for CL patients. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil. | en_US |
Affilliation | University of Brasília. Faculty of Medicine. Dermatology Service of Internal Medicine. Brasília, DF, Brazil. | en_US |
Affilliation | Federal University of Mato Grosso. Julio Muller University Hospital. Internal Medicine Department. Cuiabá, MT, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. René Rachou Institute. Clinical Research and Public Policies in Infectious Diseases. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Heitor Vieira Dourado Tropical Medicine Foundation. Dermatology Department. Manaus, AM, Brazil / Federal University of Amazonas. Dermatology Department. Manaus, AM, Brazil. | en_US |
Affilliation | Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil. | en_US |
Affilliation | Federal University of Mato Grosso do Sul. Faculty of Medicine. Campo Grande, MS, Brazil. | en_US |
Affilliation | University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil. | en_US |
Affilliation | University of São Paulo. Faculty of Medicine. Institute of Tropical Medicine. Laboratory of Parasitology, São Paulo, SP, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Epidemiology. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil / Federal University of Rio de Janeiro. Faculty of Medicine. Department of Otorhinolaryngology and Ophthalmology. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory of Clinical Research and Surveillance in Leishmaniasis. Rio de Janeiro, RJ, Brazil. | en_US |
Subject | Clinical Trial | en_US |
Subject | Meglumine Antimoniate | en_US |
Subject | Intralesional Injections | en_US |
Subject | Cutaneous Leishmaniasis | en_US |
e-ISSN | 1537-6591 | |
Embargo date | 2030-12-31 | |