Browsing by Author "Frédérique Jacobs"

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    Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial
    (2007-05-05) 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; 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
    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.