Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approac...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Fundação Oswaldo Cruz (FIOCRUZ)
2018-06-01
|
| Series: | Memorias do Instituto Oswaldo Cruz |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000900300&lng=en&tlng=en |
| _version_ | 1827831726195343360 |
|---|---|
| author | Dario Brock Ramalho Rosiana Estéfane da Silva Maria Camilo Ribeiro de Senna Hugo Silva Assis Moreira Mariana Junqueira Pedras Daniel Moreira de Avelar Lara Saraiva Ana Rabello Gláucia Cota |
| author_facet | Dario Brock Ramalho Rosiana Estéfane da Silva Maria Camilo Ribeiro de Senna Hugo Silva Assis Moreira Mariana Junqueira Pedras Daniel Moreira de Avelar Lara Saraiva Ana Rabello Gláucia Cota |
| author_sort | Dario Brock Ramalho |
| collection | DOAJ |
| description | BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions). |
| first_indexed | 2024-03-12T04:59:27Z |
| format | Article |
| id | doaj.art-292be88e430048409fb1a317da7c8d8e |
| institution | Directory Open Access Journal |
| issn | 1678-8060 |
| language | English |
| last_indexed | 2024-03-12T04:59:27Z |
| publishDate | 2018-06-01 |
| publisher | Fundação Oswaldo Cruz (FIOCRUZ) |
| record_format | Article |
| series | Memorias do Instituto Oswaldo Cruz |
| spelling | doaj.art-292be88e430048409fb1a317da7c8d8e2023-09-03T09:14:14ZengFundação Oswaldo Cruz (FIOCRUZ)Memorias do Instituto Oswaldo Cruz1678-80602018-06-01113910.1590/0074-02760180200S0074-02762018000900300Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trialDario Brock RamalhoRosiana Estéfane da SilvaMaria Camilo Ribeiro de SennaHugo Silva Assis MoreiraMariana Junqueira PedrasDaniel Moreira de AvelarLara SaraivaAna RabelloGláucia CotaBACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000900300&lng=en&tlng=enintralesional infiltrationmeglumine antimoniatecutaneous leishmaniasistherapy |
| spellingShingle | Dario Brock Ramalho Rosiana Estéfane da Silva Maria Camilo Ribeiro de Senna Hugo Silva Assis Moreira Mariana Junqueira Pedras Daniel Moreira de Avelar Lara Saraiva Ana Rabello Gláucia Cota Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial Memorias do Instituto Oswaldo Cruz intralesional infiltration meglumine antimoniate cutaneous leishmaniasis therapy |
| title | Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
| title_full | Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
| title_fullStr | Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
| title_full_unstemmed | Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
| title_short | Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial |
| title_sort | meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis a single arm open label phase ii clinical trial |
| topic | intralesional infiltration meglumine antimoniate cutaneous leishmaniasis therapy |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762018000900300&lng=en&tlng=en |
| work_keys_str_mv | AT dariobrockramalho meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT rosianaestefanedasilva meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT mariacamiloribeirodesenna meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT hugosilvaassismoreira meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT marianajunqueirapedras meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT danielmoreiradeavelar meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT larasaraiva meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT anarabello meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial AT glauciacota meglumineantimoniateintralesionalinfiltrationforlocalisedcutaneousleishmaniasisasinglearmopenlabelphaseiiclinicaltrial |