Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection

Antimicrobial Agents and Chemotherapy

Volumn 50, Issue 2, 2006, Pages 658-666

  Ullmann, A J ^a   Cornely, O A ^b   Burchardt, A ^a   Hachem, R ^c   Kontoyiannis, D P ^c   Topelt K ^b   Courtney, R ^d,e   Wexler, D ^d   Krishna, G ^d   Martinho, M ^d   Corcoran, G ^d,f   Raad, I ^c  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b UNIVERSITY OF COLOGNE   (Germany)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e PFIZER INC   (United States)

^f Stiefel   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

POSACONAZOLE;

ADULT; AGED; ALLOGENIC BONE MARROW TRANSPLANTATION; ANTIFUNGAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEMALE; HIGH RISK PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYCOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECIPIENT;

ADULT; AGED; ANTIBIOTICS, ANTIFUNGAL; BONE MARROW TRANSPLANTATION; FEMALE; FEVER; HUMANS; MALE; MIDDLE AGED; MYCOSES; NEUTROPENIA; TRIAZOLES;

EID: 31944443967     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.50.2.658-666.2006     Document Type: Article

References (33)

1. Abi-Said, D., E. Anaissie, O. Uzun, I. Raad, H. Pinzcowski, and S. Vartivarian. 1997. The epidemiology of hematogenous candidiasis caused by different Candida species. Clin. Infect. Dis. 24:1122-1128.
2. Ascioglu, S., J. H. Rex, B. de Pauw, J. E. Bennett, J. Bille, F. Crokaert, D. W. Denning, J. P. Donnelly, J. E. Edwards, Z. Erjavec, D. Fiere, O. Lortholary, J. Maertens, J. F. Meis, T. F. Patterson, J. Ritter, D. Selleslag, P. M. Shah, D. A. Stevens, and T. J. Walsh. 2002. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin. Infect. Dis. 34:7-14.
3. Baddley, J. W., T. P. Stroud, D. Salzman, and P. G. Pappas. 2001. Invasive mold infections in allogeneic bone marrow transplant recipients. Clin. Infect. Dis. 32:1319-1324.
4. Courtney, R., S. Pai, M. Laughlin, J. Lim, and V. Batra. 2003. Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults. Antimicrob. Agents Chemother. 47:2788-2795.
5. Courtney, R., A. Sansone, W. Smith, T. Marbury, P. Statkevich, M. Martinho, M. Laughlin, and S. Swan. 2005. Posaconazole pharmacokinetics, safety, and tolerability in subjects with varying degrees of chronic renal disease. J. Clin. Pharmacol. 45:185-192.
6. Courtney, R., D. Wexler, E. Radwanski, J. Lim, and M. Laughlin. 2004. Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults. Br. J. Clin. Pharmacol. 57:218-222.
7. Dannaoui, E., J. Meletiadis, J. W. Mouton, J. F. Meis, and P. E. Verweij. 2003. In vitro susceptibilities of zygomycetes to conventional and new antifungals. J. Antimicrob. Chemother. 51:45-52.
8. Denning, D. W. 1996. Therapeutic outcome in invasive aspergillosis. Clin. Infect. Dis. 23:608-615.
9. Denning, D. W., P. Ribaud, N. Milpied, D. Caillot, R. Herbrecht, E. Thiel, A. Haas, M. Ruhnke, and H. Lode. 2002. Efficacy and safety of voriconazole in the treatment of acute invasive aspergillosis. Clin. Infect. Dis. 34:563-571.
10. Diekema, D. J., S. A. Messer, R. J. Hollis, R. N. Jones, and M. A. Pfaller. 2003. Activities of caspofungin, itraconazole, posaconazole, ravuconazole, voriconazole, and amphotericin B against 448 recent clinical isolates of filamentous fungi. J. Clin. Microbiol. 41:3623-3626.
11. Ezzet, F., D. Wexler, R. Courtney, G. Krishna, J. Lim, and M. Laughlin. 2005. Oral bioavailability of posaconazole in fasted healthy subjects: comparison between three regimens and basis for clinical dosage recommendations. Clin. Pharmacokinet. 44:211-220.
12. Greenberg, R. N., L. J. Scott, H. H. Vaughn, and J. A. Ribes. 2004. Zygomycosis (mucormycosis): emerging clinical importance and new treatments. Curr. Opin. Infect. Dis. 17:517-525.
13. Herbrecht, R., S. Neuville, V. Letscher-Bru, S. Natarajan-Ame, and O. Lortholary. 2000. Fungal infections in patients with neutropenia: challenges in prophylaxis and treatment. Drugs Aging 17:339-351.
14. Husain, S., B. D. Alexander, P. Munoz, R. K. Avery, S. Houston, T. Pruett, R. Jacobs, E. A. Dominguez, J. G. Tollemar, K. Baumgarten, C. M. Yu, M. M. Wagener, P. Linden, S. Kusne, and N. Singh. 2003. Opportunistic mycelial fungal infections in organ transplant recipients: emerging importance of non-Aspergillus mycelial fungi. Clin. Infect. Dis. 37:221-229.
15. Kontoyiannis, D. P., G. P. Bodey, H. Hanna, R. Hachera, M. Boktour, E. Girgaway, M. Mardani, and I. I. Raad. 2004. Outcome determinants of fusariosis in a tertiary care cancer center: the impact of neutrophil recovery. Leukoc. Lymphoma 45:139-141.
16. Kontoyiannis, D. P., R. Hachera, R. E. Lewis, G. A. Rivero, H. A. Torres, J. Thornby, R. Champlin, H. Kantarjian, G. P. Bodey, and I. I. Raad. 2003. Efficacy and toxicity of caspofungin in combination with liposomal amphotericin B as primary or salvage treatment of invasive aspergillosis in patients with hematologic malignancies. Cancer 98:292-299.
17. Lin, S. J., J. Schranz, and S. M. Teutsch. 2001. Aspergillosis case-fatality rate: systematic review of the literature. Clin. Infect. Dis. 32:358-366.
18. Maertens, J., I. Raad, G. Petrikkos, M. Boogaerts, D. Selleslag, F. B. Petersen, C. A. Sable, N. A. Kartsonis, A. Ngai, A. Taylor, T. F. Patterson, D. W. Denning, and T. J. Walsh. 2004. Efficacy and safety of caspofungin for treatment of invasive aspergillosis in patients refractory to or intolerant of conventional antifungal therapy. Clin. Infect. Dis. 39:1563-1571.
19. Marco, F., M. A. Pfaller, S. A. Messer, and R. N. Jones. 1998. In vitro activity of a new triazole antifungal agent, Sch 56592, against clinical isolates of filamentous fungi. Mycopathologia 141:73-77.
20. Musa, M. O., A. Al Eisa, M. Halim, E. Sahovic, M. Gyger, N. Chaudhri, F. Al Mohareb, P. Seth, M. Aslam, and M. Aljurf. 2000. The spectrum of Fusarium infection in immunocompromised patients with haematological malignancies and in non-immunocompromised patients: a single institution experience over 10 years. Br. J. Haematol. 108:544-548.
21. Ng, T. T., and D. W. Denning. 1995. Liposomal amphotericin B (Am Bisome) therapy in invasive fungal infections. Evaluation of United Kingdom compassionate use data. Arch. Intern. Med. 155:1093-1098.
22. Ostrosky-Zeichner, L., J. H. Rex, P. G. Pappas, R. J. Hamill, R. A. Larsen, H. W. Horowitz, W. G. Powderly, N. Hyslop, C. A. Kauffman, J. Cleary, J. E. Mangino, and J. Lee. 2003. Antifungal susceptibility survey of 2,000 blood-stream Candida isolates in the United States. Antimicrob. Agents Chemother. 47:3149-3154.
23. Paphitou, N. I., L. Ostrosky-Zeichner, V. L. Paetznick, J. R. Rodriguez, E. Chen, and J. H. Rex. 2002. In vitro activities of investigational triazoles against Fusarium species: effects of inoculum size and incubation time on broth microdilution susceptibility test results. Antimicrob. Agents Chemother. 46:3298-3300.
24. Perfect, J. R., K. A. Marr, T. J. Walsh, R. N. Greenberg, B. DuPont, J. Torre-Cisneros, G. Just-Nubling, H. T. Schlamm, I. Lutsar, A. Espinel-Ingroff, and E. Johnson. 2003. Voriconazole treatment for less-common, emerging, or refractory fungal infections. Clin. Infect. Dis. 36:1122-1131.
25. Pfaller, M. A., S. A. Messer, L. Boyken, R. J. Hollis, C. Rice, S. Tendolkar, and D. J. Diekema. 2004. In vitro activities of voriconazole, posaconazole, and fluconazole against 4,169 clinical isolates of Candida spp. and Cryptococcus neoformans collected during 2001 and 2002 in the ARTEMIS global antifungal surveillance program. Diagn. Microbiol. Infect. Dis. 48:201-205.
26. Pfaller, M. A., S. A. Messer, R. J. Hollis, and R. N. Jones. 2001. In vitro activities of posaconazole (Sch 56592) compared with those of itraconazole and fluconazole against 3,685 clinical isolates of Candida spp. and Cryptococcus neoformans. Antimicrob. Agents Chemother. 45:2862-2864.
27. Pfaller, M. A., S. A. Messer, R. J. Hollis, and R. N. Jones. 2002. Antifungal activities of posaconazole, ravuconazole, and voriconazole compared to those of itraconazole and amphotericin B against 239 clinical isolates of Aspergillus spp. and other filamentous fungi: report from SENTRY Antimicrobial Surveillance Program, 2000. Antimicrob. Agents Chemother. 46:1032-1037.
28. Ullmann, A. J., C. P. Heussel, and O. A. Cornely. 2002. Voriconazole versus liposomal amphotericin B for empirical antifungal therapy. N. Engl. J. Med. 346:1745-1747.
29. Viscoli, C., C. Girmenia, A. Marinus, L. Collette, P. Martino, B. Vandercam, C. Doyen, B. Lebeau, D. Spence, V. Kremery, B. de Pauw, and F. Meunier. 1999. Candidemia in cancer patients: a prospective, multicenter surveillance study by the Invasive Fungal Infection Group (IFIG) of the European Organization for Research and Treatment of Cancer (EORTC). Clin. Infect. Dis. 28:1071-1079.
30. Walsh, T. J., R. W. Finberg, C. Arndt, J. Hiemenz, C. Schwartz, D. Bodensteiner, P. Pappas, N. Seibel, R. N. Greenberg, S. Dummer, M. Schuster, J. S. Holcenberg, et al. 1999. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. N. Engl. J. Med. 340:764-771.
31. Walsh, T. J., and A. H. Groll. 1999. Emerging fungal pathogens: evolving challenges to immunocompromised patients for the twenty-first century. Transpl. Infect. Dis. 1:247-261.
32. Walsh, T. J., P. Pappas, D. J. Winston, H. M. Lazarus, F. Petersen, J. Raffalli, S. Yanovich, P. Stiff, R, Greenberg, G. Donowitz, M. Schuster, A. Reboli, J. Wingard, C. Arndt, J. Reinhardt, S. Hadley, R. Finberg, M. Laverdiere, J. Perfect, G. Garber, G. Fioritoni, E. Anaissie, and J. Lee. 2002. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N. Engl. J. Med. 346:225-234.
33. Walsh, T. J., H. Teppler, G. R. Donowitz, J. A. Maertens, L. R. Baden, A. Dmoszynska, O. A. Cornely, M. R. Bourque, R. J. Lupinacci, C. A. Sable, and B. E. dePauw. 2004. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N. Engl. J. Med. 351:1391-1402.