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Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials

BACKGROUND: Invasive fungal infections cause excessive morbidity and mortality in premature neonates and severely ill infants. METHODS: Safety and efficacy outcomes of micafungin were compared between prematurely and non-prematurely born infants <2 years of age. Data were obtained from all comple...

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Autores principales: Manzoni, Paolo, Wu, Chunzhang, Tweddle, Lorraine, Roilides, Emmanuel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Williams & Wilkins 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4196786/
https://www.ncbi.nlm.nih.gov/pubmed/24892849
http://dx.doi.org/10.1097/INF.0000000000000434
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author Manzoni, Paolo
Wu, Chunzhang
Tweddle, Lorraine
Roilides, Emmanuel
author_facet Manzoni, Paolo
Wu, Chunzhang
Tweddle, Lorraine
Roilides, Emmanuel
author_sort Manzoni, Paolo
collection PubMed
description BACKGROUND: Invasive fungal infections cause excessive morbidity and mortality in premature neonates and severely ill infants. METHODS: Safety and efficacy outcomes of micafungin were compared between prematurely and non-prematurely born infants <2 years of age. Data were obtained from all completed phase I–III clinical trials with micafungin that had enrolled infants (<2 years of age) that were listed in the Astellas Clinical Study Database. Demographics, adverse events, hepatic function tests and treatment success data were extracted and validated by the Astellas biostatistical group for all micafungin-treated patients, <2 years of age, using the unique patient identifier. RESULTS: One-hundred and sixteen patients included in 9 clinical trials, 48% premature [birth weight (BW) <2500 g and/or gestational age <37 weeks], 52% non-premature, received ≥1 dose of micafungin. Among premature patients, 14.5% were low BW (1500–2499 g), 36.4% very low BW (1000–1499 g) and 49.1% extremely low BW (<1000 g). Ninety patients (78%) completed the studies; 13 [11% (4 premature)] died. Significantly more non-premature than premature patients discontinued treatment (P = 0.003). Treatment-related adverse events were recorded in 23% of patients with no difference between groups. More extremely low BW (n = 4, 15%) and very low BW (n = 8, 40%) infants experienced treatment-related adverse events than low BW (n = 0) and there was no relation to micafungin dose or duration. For a subgroup of 30 patients with invasive candidiasis, treatment success was achieved in 73% in both premature and non-premature groups. Prophylaxis was successful in 4/5 non-premature hematopoietic stem cell transplant patients. CONCLUSION: Micafungin has a safe profile in premature and non-premature infants with substantial efficacy.
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spelling pubmed-41967862014-10-16 Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials Manzoni, Paolo Wu, Chunzhang Tweddle, Lorraine Roilides, Emmanuel Pediatr Infect Dis J Antimicrobial Reports BACKGROUND: Invasive fungal infections cause excessive morbidity and mortality in premature neonates and severely ill infants. METHODS: Safety and efficacy outcomes of micafungin were compared between prematurely and non-prematurely born infants <2 years of age. Data were obtained from all completed phase I–III clinical trials with micafungin that had enrolled infants (<2 years of age) that were listed in the Astellas Clinical Study Database. Demographics, adverse events, hepatic function tests and treatment success data were extracted and validated by the Astellas biostatistical group for all micafungin-treated patients, <2 years of age, using the unique patient identifier. RESULTS: One-hundred and sixteen patients included in 9 clinical trials, 48% premature [birth weight (BW) <2500 g and/or gestational age <37 weeks], 52% non-premature, received ≥1 dose of micafungin. Among premature patients, 14.5% were low BW (1500–2499 g), 36.4% very low BW (1000–1499 g) and 49.1% extremely low BW (<1000 g). Ninety patients (78%) completed the studies; 13 [11% (4 premature)] died. Significantly more non-premature than premature patients discontinued treatment (P = 0.003). Treatment-related adverse events were recorded in 23% of patients with no difference between groups. More extremely low BW (n = 4, 15%) and very low BW (n = 8, 40%) infants experienced treatment-related adverse events than low BW (n = 0) and there was no relation to micafungin dose or duration. For a subgroup of 30 patients with invasive candidiasis, treatment success was achieved in 73% in both premature and non-premature groups. Prophylaxis was successful in 4/5 non-premature hematopoietic stem cell transplant patients. CONCLUSION: Micafungin has a safe profile in premature and non-premature infants with substantial efficacy. Williams & Wilkins 2014-11 2014-10-14 /pmc/articles/PMC4196786/ /pubmed/24892849 http://dx.doi.org/10.1097/INF.0000000000000434 Text en Copyright © 2014 by Lippincott Williams & Wilkins. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
spellingShingle Antimicrobial Reports
Manzoni, Paolo
Wu, Chunzhang
Tweddle, Lorraine
Roilides, Emmanuel
Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title_full Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title_fullStr Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title_full_unstemmed Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title_short Micafungin in Premature and Non-premature Infants: A Systematic Review of 9 Clinical Trials
title_sort micafungin in premature and non-premature infants: a systematic review of 9 clinical trials
topic Antimicrobial Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4196786/
https://www.ncbi.nlm.nih.gov/pubmed/24892849
http://dx.doi.org/10.1097/INF.0000000000000434
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