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 evaluat...
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| Language: | English |
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Sociedade Brasileira de Medicina Tropical (SBMT)
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| Series: | Revista da Sociedade Brasileira de Medicina Tropical |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&tlng=en |
| _version_ | 1818265100703760384 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-12T19:45:26Z |
| format | Article |
| id | doaj.art-ce8821cd1e4d424ab5c037198b1c6980 |
| institution | Directory Open Access Journal |
| issn | 1678-9849 |
| language | English |
| last_indexed | 2024-12-12T19:45:26Z |
| publisher | Sociedade Brasileira de Medicina Tropical (SBMT) |
| record_format | Article |
| series | Revista da Sociedade Brasileira de Medicina Tropical |
| spelling | doaj.art-ce8821cd1e4d424ab5c037198b1c69802022-12-22T00:14:06ZengSociedade Brasileira de Medicina Tropical (SBMT)Revista da Sociedade Brasileira de Medicina Tropical1678-9849501677410.1590/0037-8682-0455-2016S0037-86822017000100067Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in BrazilMyrlena Mescouto BorgesMaria Cristina da Silva PrancheviciusElza Ferreira NoronhaGustavo Adolfo Sierra RomeroCésar Omar Carranza-TamayoABSTRACT 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&tlng=enVisceral leishmaniasisChildrenClinical trialBrazil |
| spellingShingle | 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 Revista da Sociedade Brasileira de Medicina Tropical Visceral leishmaniasis Children Clinical trial Brazil |
| 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_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_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_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 |
| topic | Visceral leishmaniasis Children Clinical trial Brazil |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&tlng=en |
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