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 |
|