Publication: Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial
Issued Date
2007-05-05
Resource Type
ISSN
01406736
Other identifier(s)
2-s2.0-34247564562
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Mahidol University
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SCOPUS
Bibliographic Citation
Lancet. Vol.369, No.9572 (2007), 1519-1527
Suggested Citation
Ernst Rüdiger Kuse, Ploenchan Chetchotisakd, Clovis Arns da Cunha, Markus Ruhnke, Carlos Barrios, Digumarti Raghunadharao, Jagdev Singh Sekhon, Antonio Freire, Venkatasubramanian Ramasubramanian, Ignace Demeyer, Marcio Nucci, Amorn Leelarasamee, Frédérique Jacobs, Johan Decruyenaere, Didier Pittet, Andrew J. Ullmann, Luis Ostrosky-Zeichner, Olivier Lortholary, Sonja Koblinger, Heike Diekmann-Berndt, Oliver A. Cornely Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet. Vol.369, No.9572 (2007), 1519-1527. doi:10.1016/S0140-6736(07)60605-9 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/24872
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Title
Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial
Author(s)
Ernst Rüdiger Kuse
Ploenchan Chetchotisakd
Clovis Arns da Cunha
Markus Ruhnke
Carlos Barrios
Digumarti Raghunadharao
Jagdev Singh Sekhon
Antonio Freire
Venkatasubramanian Ramasubramanian
Ignace Demeyer
Marcio Nucci
Amorn Leelarasamee
Frédérique Jacobs
Johan Decruyenaere
Didier Pittet
Andrew J. Ullmann
Luis Ostrosky-Zeichner
Olivier Lortholary
Sonja Koblinger
Heike Diekmann-Berndt
Oliver A. Cornely
Ploenchan Chetchotisakd
Clovis Arns da Cunha
Markus Ruhnke
Carlos Barrios
Digumarti Raghunadharao
Jagdev Singh Sekhon
Antonio Freire
Venkatasubramanian Ramasubramanian
Ignace Demeyer
Marcio Nucci
Amorn Leelarasamee
Frédérique Jacobs
Johan Decruyenaere
Didier Pittet
Andrew J. Ullmann
Luis Ostrosky-Zeichner
Olivier Lortholary
Sonja Koblinger
Heike Diekmann-Berndt
Oliver A. Cornely
Other Contributor(s)
Klinik für Viszeral- und Transplantationschirurgie
Khon Kaen University
R Desembargador Vieira Cavalcante
Charité – Universitätsmedizin Berlin
Pontificia Universidade Catolica do Rio Grande do Sul
Nizam's Institute of Medical Sciences
Dayanand Medical College and Hospital
Santa Casa de Belo Horizonte
Apollo Hospitals
Onze Lieve Vrouw Hospital
Universidade Federal do Rio de Janeiro
Mahidol University
Hospital Erasme
University Hospital of Ghent
Hopitaux universitaires de Geneve
Klinikum der Johannes-Gutenberg-Universitat und Fachbereich Medizin
University of Texas Medical School at Houston
Hopital Necker Enfants Malades
Astellas Pharma GmbH
Uniklinik Koln
Khon Kaen University
R Desembargador Vieira Cavalcante
Charité – Universitätsmedizin Berlin
Pontificia Universidade Catolica do Rio Grande do Sul
Nizam's Institute of Medical Sciences
Dayanand Medical College and Hospital
Santa Casa de Belo Horizonte
Apollo Hospitals
Onze Lieve Vrouw Hospital
Universidade Federal do Rio de Janeiro
Mahidol University
Hospital Erasme
University Hospital of Ghent
Hopitaux universitaires de Geneve
Klinikum der Johannes-Gutenberg-Universitat und Fachbereich Medizin
University of Texas Medical School at Houston
Hopital Necker Enfants Malades
Astellas Pharma GmbH
Uniklinik Koln
Abstract
Background: Invasive candidosis is increasingly prevalent in seriously ill patients. Our aim was to compare micafungin with liposomal amphotericin B for the treatment of adult patients with candidaemia or invasive candidosis. Methods: We did a double-blind, randomised, multinational non-inferiority study to compare micafungin (100 mg/day) with liposomal amphotericin B (3 mg/kg per day) as first-line treatment of candidaemia and invasive candidosis. The primary endpoint was treatment success, defined as both a clinical and a mycological response at the end of treatment. Primary analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT00106288. Findings: 264 individuals were randomly assigned to treatment with micafungin; 267 were randomly assigned to receive liposomal amphotericin B. 202 individuals in the micafungin group and 190 in the liposomal amphotericin B group were included in the per-protocol analyses. Treatment success was observed for 181 (89·6%) patients treated with micafungin and 170 (89·5%) patients treated with liposomal amphotericin B. The difference in proportions, after stratification by neutropenic status at baseline, was 0·7% (95% CI -5·3 to 6·7). Efficacy was independent of the Candida spp and primary site of infection, as well as neutropenic status, APACHE II score, and whether a catheter was removed or replaced during the study. There were fewer treatment-related adverse events-including those that were serious or led to treatment discontinuation-with micafungin than there were with liposomal amphotericin B. Interpretation: Micafungin was as effective as-and caused fewer adverse events than-liposomal amphotericin B as first-line treatment of candidaemia and invasive candidosis. © 2007 Elsevier Ltd. All rights reserved.
