Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial

Kuse, E. R.; Chetchotisakd, Ploenchan; da Cunha, C. A.; Ruhnke, Markus; Barrios, Carlos; Raghunadharao, Digumarti; Sekhon, J. S.; Freire, Antonio; Ramasubramanian, Venkatasubramanian; Demeyer, Ignace; Nucci, Marcio; Leelarasamee, Amorn; Jacobs, Frederique; Decruyenaere, Johan; Pittet, Didier; Ullmann, A. J.; Ostrosky-Zeichner, Luis; Lortholary, Olivier; Koblinger, Sonja; Diekmann-Berndt, Heike; Cornely, O. A.

doi:10.1016/S0140-6736(07)60605-9

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Title		Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial
Authors		Kuse, E. R. Chetchotisakd, Ploenchan da Cunha, C. A. Ruhnke, Markus Barrios, Carlos Raghunadharao, Digumarti Sekhon, J. S. Freire, Antonio Ramasubramanian, Venkatasubramanian Demeyer, Ignace Nucci, Marcio Leelarasamee, Amorn Jacobs, Frederique Decruyenaere, Johan Pittet, Didier Ullmann, A. J. Ostrosky-Zeichner, Luis Lortholary, Olivier Koblinger, Sonja Diekmann-Berndt, Heike Cornely, O. A. show all authors [1 - 21]
Published in		The Lancet. 2007, vol. 369, no. 9572, p. 1519-1527
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.
Keywords		Apache — Adolescent — Adult — Aged — Aged, 80 and over — Amphotericin B/ therapeutic use — Antifungal Agents/ therapeutic use — Candidiasis/complications/ drug therapy/microbiology — Double-Blind Method — Echinocandins — Female — Humans — Lipopeptides — Lipoproteins/ therapeutic use — Male — Microbial Sensitivity Tests — Middle Aged — Peptides, Cyclic/ therapeutic use — Treatment Outcome
Identifiers		DOI: 10.1016/S0140-6736(07)60605-9 PMID: 17482982
Full text		Article - Limited access to UNIGE
Structures		Faculté de médecine / Section de médecine clinique / Département de médecine
Research group		Staphylocoques dorés résistants à la méthicilline et hygiène hospitalière (330)
Citation (ISO format)		KUSE, E. R. et al. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. In: The Lancet, 2007, vol. 369, n° 9572, p. 1519-1527. doi: 10.1016/S0140-6736(07)60605-9 https://archive-ouverte.unige.ch/unige:7396