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dc.contributor.author | Lopez, Liliana | |
dc.contributor.author | Alvarez, Fiorela | |
dc.contributor.author | Ramos, Ana Pilar | |
dc.contributor.author | Llanos Cuentas, Elmer Alejandro | |
dc.contributor.author | Echevarria Zarate, Juan Ignacio | |
dc.contributor.author | Velez, Ivan | |
dc.contributor.author | Boni, Marina | |
dc.contributor.author | Rode, Joelle | |
dc.contributor.author | Quintero, Juliana | |
dc.contributor.author | Jimenez, Alejandra | |
dc.contributor.author | Tabares, Yulied | |
dc.contributor.author | Mendez, Claudia | |
dc.contributor.author | Arana, Byron | |
dc.date.accessioned | 2022-03-23T16:54:19Z | |
dc.date.available | 2022-03-23T16:54:19Z | |
dc.date.issued | 2022 | |
dc.identifier.uri | https://hdl.handle.net/20.500.12866/11459 | |
dc.description.abstract | Background: Systemic pentavalent antimonials, mainly meglumine antimoniate, continue to be the first-choice drugs for treatment of cutaneous leishmaniasis (CL) despite their toxicity, difficulty of administration and high cost. In the search for therapeutic alternatives, combining two treatment interventions has emerged as a potential alternative to either reduce the use of antimonials with the associated toxicities, or to increase efficacy. Here, we report the results of a recently completed trial assessing the efficacy and safety of a combination of thermotherapy (TT) plus a short course of miltefosine (MLT) for the treatment of uncomplicated CL in Colombia and Peru. Methods: A multicenter, randomized, evaluator-blinded, phase II, controled clinical trial was conducted. Adult volunteers with a parasitologically confirmed diagnosis of uncomplicated CL were randomly allocated to receive either a single session of TT or a combination of TT plus a short course of MLT (3 weeks). Therapeutic response outcomes and safety were assessed. Results: 130 subjects were included in the study, of whom 64 were randomly assigned to the TT arm and 66 to the TT + MLT arm. Cure at 3 months’ follow-up was achieved in 57.8% (n = 37) and 80.3% (n = 53) in the TT and TT + MLT groups, respectively, in the intention to treat analysis. The TT + MLT regimen was better that TT alone (p = 0.0055). The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31.8%) and elevation of liver enzymes (28.8%) were the most frequent adverse events reported associated with the use of MLT. Conclusion: The combination of TT plus a short course of MLT was shown to be significantly better than TT alone for the treatment of uncomplicated CL in the New World. | en_US |
dc.language.iso | eng | |
dc.publisher | Public Library of Science | |
dc.relation.ispartofseries | PLoS Neglected Tropical Diseases | |
dc.rights | info:eu-repo/semantics/restrictedAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es | |
dc.subject | phase II multicenter randomized study | en_US |
dc.subject | safety and efficacy | en_US |
dc.subject | thermotherapy | en_US |
dc.subject | short course | en_US |
dc.subject | miltefosine | en_US |
dc.subject | treatment | en_US |
dc.subject | cutaneous leishmaniasis | en_US |
dc.title | A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. | en_US |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | https://doi.org/10.1371/journal.pntd.0010238 | |
dc.relation.issn | 1935-2735 |
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