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.
<h4>Background</h4>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...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2022-03-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0010238 |
| _version_ | 1798029250509406208 |
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| author | Liliana López Braulio Valencia Fiorela Alvarez Ana Pilar Ramos Alejandro Llanos-Cuentas Juan Echevarria Iván Vélez Marina Boni Joelle Rode Juliana Quintero Alejandra Jiménez Yulied Tabares Claudia Méndez Byron Arana |
| author_facet | Liliana López Braulio Valencia Fiorela Alvarez Ana Pilar Ramos Alejandro Llanos-Cuentas Juan Echevarria Iván Vélez Marina Boni Joelle Rode Juliana Quintero Alejandra Jiménez Yulied Tabares Claudia Méndez Byron Arana |
| author_sort | Liliana López |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>Registered in clinicaltrials.gov NCT02687971. |
| first_indexed | 2024-04-11T19:22:18Z |
| format | Article |
| id | doaj.art-7d38ed91d4fd43ceaad0a96cea2a20d1 |
| institution | Directory Open Access Journal |
| issn | 1935-2727 1935-2735 |
| language | English |
| last_indexed | 2024-04-11T19:22:18Z |
| publishDate | 2022-03-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj.art-7d38ed91d4fd43ceaad0a96cea2a20d12022-12-22T04:07:17ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352022-03-01163e001023810.1371/journal.pntd.0010238A 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.Liliana LópezBraulio ValenciaFiorela AlvarezAna Pilar RamosAlejandro Llanos-CuentasJuan EchevarriaIván VélezMarina BoniJoelle RodeJuliana QuinteroAlejandra JiménezYulied TabaresClaudia MéndezByron Arana<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>Registered in clinicaltrials.gov NCT02687971.https://doi.org/10.1371/journal.pntd.0010238 |
| spellingShingle | Liliana López Braulio Valencia Fiorela Alvarez Ana Pilar Ramos Alejandro Llanos-Cuentas Juan Echevarria Iván Vélez Marina Boni Joelle Rode Juliana Quintero Alejandra Jiménez Yulied Tabares Claudia Méndez Byron Arana 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. PLoS Neglected Tropical Diseases |
| 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://doi.org/10.1371/journal.pntd.0010238 |
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