Kuse, Ernst-Rüdiger ; Chetchotisakd, Ploenchan ; da Cunha, Clovis Arns ; Ruhnke, Markus ; Barrios, Carlos ; Raghunadharao, Digumarti ; Sekhon, Jagdev Singh ; Freire, Antonio ; Ramasubramanian, Venkatasubramanian ; Demeyer, Ignace ; Nucci, Marcio ; Leelarasamee, Amorn ; Jacobs, Frédérique ; Decruyenaere, Johan ; Pittet, Didier ; Ullmann, Andrew J. ; Ostrosky-Zeichner, Luis ; Lortholary, Olivier ; Koblinger, Sonja ; Diekmann-Berndt, Heike ; Cornely, Oliver A. ; Sharma, S. K. (2007) Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a Phase III randomised double-blind trial The Lancet, 369 (9572). pp. 1519-1527. ISSN 0023-7507
Full text not available from this repository.
Official URL: http://www.sciencedirect.com/science/article/pii/S...
Related URL: http://dx.doi.org/10.1016/S0140-6736(07)60605-9
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.
Item Type: | Article |
---|---|
Source: | Copyright of this article belongs to Elsevier Science. |
ID Code: | 69363 |
Deposited On: | 10 Nov 2011 10:20 |
Last Modified: | 10 Nov 2011 10:20 |
Repository Staff Only: item control page