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JAC Advance Access published online on August 31, 2005
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dki288
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org
Received April 8, 2005
Revised July 14, 2005
Accepted July 24, 2005

Original article

Activity of posaconazole in the treatment of central nervous system fungal infections

Punnee Pitisuttithum 1*, Ricardo Negroni 2, John R. Graybill 3, Beatriz Bustamante 4, Peter Pappas 5, Stanley Chapman 6, Roberta S. Hare 7, and Catherine J. Hardalo 7

1 Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok 10400, Thailand
2 Hospital FJ Muñiz, Buenos Aires, Argentina
3 University of Texas Health Sciences Center, San Antonio, TX, USA
4 Hospital Nacional Cayetano Heredia, Lima, Peru
5 University of Alabama at Birmingham, Birmingham, AL
6 University of Mississippi Medical Center Division of Infectious Diseases, Jackson, MS
7 Schering-Plough Research Institute, Kenilworth, NJ, USA

* To whom correspondence should be addressed.
Punnee Pitisuttithum, E-mail: tmppt{at}mahidol.ac.th; punneep@dmc.inet.co.th


  Abstract

Objectives: A multinational, multicentre, open-label clinical trial was conducted to evaluate the safety and efficacy of posaconazole, an extended-spectrum triazole antifungal agent, in subjects with invasive fungal infections who had refractory disease or who were intolerant of standard antifungal therapy. In this subanalysis, we report on those subjects in this trial who had a fungal infection that involved the CNS.

Methods: Subjects received posaconazole oral suspension 800 mg/day in divided doses for up to 1 year; however, subjects could receive additional therapy as part of a treatment-use extension protocol. A blinded, third-party data review committee determined subject eligibility and outcome.

Results: Of the 330 subjects who enrolled in the study, 53 had infections of the CNS, of which 39 were considered evaluable for efficacy. Most had refractory disease (37 of 39) and underlying HIV infection (29 of 39). Twenty-nine subjects had cryptococcal infections, and 10 had infections caused by other fungal pathogens [Aspergillus spp. (four), Pseudallescheria boydii (two), Coccidioides immitis (one), Histoplasma capsulatum (one), Ramichloridium mackenziei (one), and Apophysomyces elegans plus a Basidiomycetes sp. (one)]. Successful outcomes were observed in 14 of 29 (48%) subjects with cryptococcal meningitis and five of 10 (50%) subjects with CNS infections due to other fungal pathogens. Posaconazole was well tolerated.

Conclusions: These data suggest that posaconazole, as an oral medication, has clinical activity against fungal infections of the CNS and may provide a valuable alternative to parenteral therapy in patients failing existing antifungal agents.

Keywords: salvage treatment; cryptococcal infections; triazoles; invasive.
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