Author | Lyra, Marcelo R | |
Author | Oliveira, Liliane F A | |
Author | Schubach, Armando O | |
Author | Sampaio, Raimunda N | |
Author | Rodrigues, Bruna C | |
Author | Hueb, Márcia | |
Author | Cota, Gláucia Fernandes | |
Author | Silva, Rosiana Estéfane da | |
Author | Francesconi, Fábio | |
Author | Pompilio, Maurício A | |
Author | Oliveira, Adriana F | |
Author | Amato, Valdir S | |
Author | Souza, Regina M | |
Author | Oliveira, Raquel V C | |
Author | Rosalino, Cláudia M V | |
Author | Pimentel, Maria I F | |
Access date | 2023-05-11T14:33:21Z | |
Available date | 2023-05-11T14:33:21Z | |
Document date | 2023 | |
Citation | LYRA, Marcelo R et al. A randomized, controlled, non-inferiority, multicenter trial of systemic versus intralesional treatment with meglumine antimoniate for cutaneous leishmaniasis in Brazil. Clin. infect. dis, ciad253, 2023. doi: 10.1093/cid/ciad253. | en_US |
ISSN | 1058-4838 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/58319 | |
Language | eng | en_US |
Publisher | The University of Chicago Press | en_US |
Rights | restricted access | en_US |
Title | A randomized, controlled, non-inferiority, multicenter trial of systemic versus intralesional treatment with meglumine antimoniate for cutaneous leishmaniasis in Brazil | en_US |
Type | Article | en_US |
Abstract | Background: Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL), despite its high toxicity. Uncontrolled studies suggest that intralesional infiltration of MA (IL-MA) may be non-inferior in efficacy and safer than systemic (S-MA).
Methods: Multicenter, randomized, controlled, open-label, phase III clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared to S-MA (10 to 20 mg Sb5+/kg/day, 20 days) for CL. Primary and secondary outcomes were respectively definitive cure at day 180 and epithelialization rate at day 90 of treatment. A non-inferiority margin of 20% was used to estimate the minimum sample. A two-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AE) were monitored according to The DAIDS AE Grading.
Results: This study evaluated 135 patients. The cure rates (confidence interval 95%) of 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. AE in IL-MA and S-MA groups were respectively: clinical 45.6%, 80.6%; laboratory 26.5%, 73.1%; EKG 8.8%, 25.4%. Ten participants in the S-MA and one in the IL-MA group were discontinued due to severe or persistent AEs.
Conclusion: IL-MA provides similar cure rate and results in less toxicity compared to S-MA in CL patients. IL-MA may be used as first line therapy for CL. | en_US |
Affilliation | Laboratory of Clinical Research and Surveillance in Leishmaniasis. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Laboratory of Clinical Research and Surveillance in Leishmaniasis. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Laboratory of Clinical Research and Surveillance in Leishmaniasis. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Faculty of Medicine. University of Brasília. Brasília, DF, Brazil. | en_US |
Affilliation | Faculty of Medicine. University of Brasília. Brasília, DF, Brazil. | en_US |
Affilliation | Julio Muller University Hospital. Federal University of Mato Grosso. Cuiabá, MT, Brazil. | en_US |
Affilliation | René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | René Rachou Institute. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Heitor Vieira Dourado Tropical Medicine Foundation. Manaus, AM, Brazil/ Federal University of Amazonas. Manaus, AM, Brazil. | en_US |
Affilliation | Faculty of Medicine. Federal University of Mato Grosso do Sul. Campo Grande, MS, Brazil. | en_US |
Affilliation | Faculty of Medicine. Federal University of Mato Grosso do Sul. Campo Grande, MS, Brazil. | en_US |
Affilliation | Laboratory of Parasitology. Institute of Tropical Medicine. Faculty of Medicine. University of São Paulo. São Paulo, SP, Brazil. | en_US |
Affilliation | Laboratory of Parasitology. Institute of Tropical Medicine. Faculty of Medicine. University of São Paulo. São Paulo, SP, Brazil. | en_US |
Affilliation | Laboratory of Epidemiology. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Laboratory of Clinical Research and Surveillance in Leishmaniasis. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Laboratory of Clinical Research and Surveillance in Leishmaniasis. Evandro Chagas National Institute of Infectious Diseases. Oswaldo Cruz Foundation. Rio de Janeiro, RJ, Brazil. | en_US |
Subject | American tegumentary leishmaniasis | en_US |
Subject | clinical trial | en_US |
Subject | cutaneous leishmaniasis | en_US |
Subject | intralesional treatment | en_US |
Subject | meglumine antimoniate | en_US |
Subject | therapy | en_US |
Subject | toxicity | en_US |
Embargo date | 2099-12-31 | |