Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil
ABSTRACT INTRODUCTION Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate...
Published in: | Revista da Sociedade Brasileira de Medicina Tropical |
---|---|
Main Authors: | , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Sociedade Brasileira de Medicina Tropical (SBMT)
|
Subjects: | |
Online Access: | https://doi.org/10.1590/0037-8682-0455-2016 https://doaj.org/article/ce8821cd1e4d424ab5c037198b1c6980 |
id |
ftdoajarticles:oai:doaj.org/article:ce8821cd1e4d424ab5c037198b1c6980 |
---|---|
record_format |
openpolar |
spelling |
ftdoajarticles:oai:doaj.org/article:ce8821cd1e4d424ab5c037198b1c6980 2023-05-15T15:12:53+02:00 Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil Myrlena Mescouto Borges Maria Cristina da Silva Pranchevicius Elza Ferreira Noronha Gustavo Adolfo Sierra Romero César Omar Carranza-Tamayo https://doi.org/10.1590/0037-8682-0455-2016 https://doaj.org/article/ce8821cd1e4d424ab5c037198b1c6980 EN eng Sociedade Brasileira de Medicina Tropical (SBMT) http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&tlng=en https://doaj.org/toc/1678-9849 1678-9849 doi:10.1590/0037-8682-0455-2016 https://doaj.org/article/ce8821cd1e4d424ab5c037198b1c6980 Revista da Sociedade Brasileira de Medicina Tropical, Vol 50, Iss 1, Pp 67-74 Visceral leishmaniasis Children Clinical trial Brazil Arctic medicine. Tropical medicine RC955-962 article ftdoajarticles https://doi.org/10.1590/0037-8682-0455-2016 2022-12-31T03:21:41Z ABSTRACT INTRODUCTION Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. RESULTS In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. CONCLUSIONS N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Revista da Sociedade Brasileira de Medicina Tropical 50 1 67 74 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Visceral leishmaniasis Children Clinical trial Brazil Arctic medicine. Tropical medicine RC955-962 |
spellingShingle |
Visceral leishmaniasis Children Clinical trial Brazil Arctic medicine. Tropical medicine RC955-962 Myrlena Mescouto Borges Maria Cristina da Silva Pranchevicius Elza Ferreira Noronha Gustavo Adolfo Sierra Romero César Omar Carranza-Tamayo Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
topic_facet |
Visceral leishmaniasis Children Clinical trial Brazil Arctic medicine. Tropical medicine RC955-962 |
description |
ABSTRACT INTRODUCTION Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. RESULTS In total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. CONCLUSIONS N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL. |
format |
Article in Journal/Newspaper |
author |
Myrlena Mescouto Borges Maria Cristina da Silva Pranchevicius Elza Ferreira Noronha Gustavo Adolfo Sierra Romero César Omar Carranza-Tamayo |
author_facet |
Myrlena Mescouto Borges Maria Cristina da Silva Pranchevicius Elza Ferreira Noronha Gustavo Adolfo Sierra Romero César Omar Carranza-Tamayo |
author_sort |
Myrlena Mescouto Borges |
title |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
title_short |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
title_full |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
title_fullStr |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
title_full_unstemmed |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil |
title_sort |
efficacy and safety of amphotericin b deoxycholate versus n-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in brazil |
publisher |
Sociedade Brasileira de Medicina Tropical (SBMT) |
url |
https://doi.org/10.1590/0037-8682-0455-2016 https://doaj.org/article/ce8821cd1e4d424ab5c037198b1c6980 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista da Sociedade Brasileira de Medicina Tropical, Vol 50, Iss 1, Pp 67-74 |
op_relation |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&tlng=en https://doaj.org/toc/1678-9849 1678-9849 doi:10.1590/0037-8682-0455-2016 https://doaj.org/article/ce8821cd1e4d424ab5c037198b1c6980 |
op_doi |
https://doi.org/10.1590/0037-8682-0455-2016 |
container_title |
Revista da Sociedade Brasileira de Medicina Tropical |
container_volume |
50 |
container_issue |
1 |
container_start_page |
67 |
op_container_end_page |
74 |
_version_ |
1766343515626799104 |