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Lancet. 2007 May 5;369(9572):1519-1527. doi: 10.1016/S0140-6736(07)60605-9.

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

Author information

1
Klinik für Viszeral und Transplantationschirurgie, Hannover, Germany.
2
Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.
3
R Desembargador Vieira Cavalcante, Curitiba, Brazil.
4
Charité-Universitätsmedizin Berlin, Berlin, Germany.
5
Hospital Sao Lucas da PUCRS, Porto Alegre, Brazil.
6
Nizam's Institute of Medical Sciences, Hyderabad, India.
7
Dayanand Medical College and Hospital, Ludhiana, India.
8
Santa Casa de Misericordia de Belo Horizonte Santa Efigenia, Belo Horizonte, Brazil.
9
Apollo Hospitals, Chennai, India.
10
OLV Ziekenhuis Aalst, Aalst, Belgium.
11
Hospital Universitario Clementino Fraga Filko UFRJ, Rio de Janeiro, Brazil.
12
Siriraj Hospital, Mahidol University, Bangkok, Thailand.
13
Hopital Erasme - ULB, Brussels, Belgium.
14
UZ Gent, Gent, Belgium.
15
University of Geneva Hospitals, Geneva, Switzerland.
16
Klinikum der Johannes-Gutenberg-Universität, Mainz, Germany.
17
University of Texas Medical School, Houston, TX, USA.
18
U Paris V, Hôpital Necker-Enfants Malades and Institut Pasteur, Paris, France.
19
Astellas Pharma GmbH, Munich, Germany.
20
Universitätsklinik Köln, Klinik I für Innere Medizin, Köln, Germany. Electronic address: Oliver.Cornely@ctuc.de.

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.

PMID:
17482982
DOI:
10.1016/S0140-6736(07)60605-9
[Indexed for MEDLINE]

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