These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling. Drug Details Company Name Business Partner Drug Name Generic Name Unique ID Studied Indications or Disease Phase Approved Drug Label Schering-Plough Corporation NOXAFIL posaconazole P02952 Infections, Fungal Infections, Fungal, Pediatric Phase III FDA-approved label may be found by following the links to NOXAFIL label information at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Clinical Study Summary Protocol P02952: Data Review Committee Procedures and Analysis for the Comparison of Data From P00041 and P02387 (synopsis below) Protocol P00041: Open-Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections (synopsis below) Protocol P02387: A Retrospective Study to Establish a Historic Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infection (synopsis below) Krishna G, Sansone-Parsons A, Martinho M, Kantesaria B, Pedicone L. Posaconazole plasma concentrations in juvenile patients with invasive fungal infection. Antimicrob Agents Chemother 2007;51:812-8. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17210771&ordinalpos=48&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum Walsh TJ, Raad I, Patterson TF, Chandrasekar P, Donowitz GR, Graybill R, et al. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial. Clin Infect Dis 2007;44:2-12. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17143808&query_hl=3&itool=pubmed_docsum http://www.journals.uchicago.edu/CID/journal/issues/v44n1/39344/39344.web.pdf Raad II, Hachem RY, Herbrecht R, Graybill JR, Hare R, Corcoran G, et al. Posaconazole as salvage treatment for invasive fusariosis in patients with underlying hematologic malignancy and other conditions. Clin Infect Dis 2006;42:1398-403. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16619151&query_hl=1&itool=pubmed_docsum http://www.journals.uchicago.edu/CID/journal/issues/v42n10/38411/38411.web.pdf Anstead GM, Martinez M, Graybill JR. Control of a Candida glabrata prosthetic endovascular infection with posaconazole. Med Mycol 2006;44:273-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16702108&query_hl=1&itool=pubmed_docsum Greenberg RN, Mullane K, van Burik JA, Raad I, Abzug MJ, Anstead G, et al. Posaconazole as salvage therapy for zygomycosis. Antimicrob Agents Chemother 2006;50:126-33. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16377677&query_hl=1&itool=pubmed_docsum http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1346806&blobtype=pdf Negroni R, Tobon A, Bustamante B, Shikanai-Yasuda MA, Patino H, Restrepo A. Posaconazole treatment of refractory eumycetoma and chromoblastomycosis. Rev Inst Med Trop Sao Paulo 2005;47:339-46. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16553324&query_hl=1&itool=pubmed_docsum Pitisuttithum P, Negroni R, Graybill JR, Bustamante B, Pappas P, Chapman S, et al. Activity of posaconazole in the treatment of central nervous system fungal infections. J Antimicrob Chemother 2005;56:745-55. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16135526&query_hl=1&itool=pubmed_DocSum http://jac.oxfordjournals.org/cgi/reprint/56/4/745 Leather HL, Correll TA, Meyer CL, Schmalfuss IM, Wingard JR. Treatment of zygomycosis with posaconazole in a patient with acute myeloid leukemia. Clin Adv Hematol Oncol 2005;3:773-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16258487&query_hl=1&itool=pubmed_docsum Clark B, Foster R, Tunbridge A, Green S. A case of disseminated histoplasmosis successfully treated with the investigational drug posaconazole. J Infect 2005;51:e177-80. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16230202&query_hl=1&itool=pubmed_DocSum http://www.sciencedirect.com/science?_ob=MImg&_imagekey=B6WJT-4FKXGRY-1-1&_cdi=6887&_user=4442&_orig=search&_coverDate=10%2F31%2F2005&_qd=1&_sk=999489996&view=c&_alid=451529214&_rdoc=1&wchp=dGLbVzz-zSkWA&md5=7486f1a7dacb11d4b89eb98535398b3b&ie=/sdarticle.pdf Anstead GM, Corcoran G, Lewis J, Berg D, Graybill JR. Refractory coccidioidomycosis treated with posaconazole. Clin Infect Dis 2005;40:1770-6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15909265&query_hl=2&itool=pubmed_docsum http://www.journals.uchicago.edu/CID/journal/issues/v40n12/35170/35170.web.pdf Segal BH, Barnhart LA, Anderson VL, Walsh TJ, Malech HL, Holland SM. Posaconazole as salvage therapy in patients with chronic granulomatous disease and invasive filamentous fungal infection. Clin Infect Dis 2005;40:1684-8. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15889369&query_hl=1&itool=pubmed_DocSum http://www.journals.uchicago.edu/CID/journal/issues/v40n11/35756/35756.web.pdf Al-Abdely HM, Alkhunaizi AM, Al-Tawfiq JA, Hassounah M, Rinaldi MG, Sutton DA. Successful therapy of cerebral phaeohyphomycosis due to Ramichloridium mackenziei with the new triazole posaconazole. Med Mycol 2005;43:91-5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15712614&query_hl=1&itool=pubmed_DocSum Herbrecht R, Kessler R, Kravanja C, Meyer MH, Waller J, Letscher-Bru V. Successful treatment of Fusarium proliferatum pneumonia with posaconazole in a lung transplant recipient. J Heart Lung Transplant 2004;23:1451-4. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15607679&query_hl=26&itool=pubmed_docsum http://www.jhltonline.org/article/PIIS1053249803005199/abstract Tobon AM, Correa AL, Arango M, de Bedout C, Restrepo A. Posaconazole therapy for severe abdominal candidiasis: a case report. Rev Iberoam Micol 2004;21:79-81. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15538832&query_hl=1&itool=pubmed_DocSum http://www.reviberoammicol.com/2004-21/079081.pdf Lodge BA, Ashley ED, Steele MP, Perfect JR. Aspergillus fumigatus empyema, arthritis, and calcaneal osteomyelitis in a lung transplant patient successfully treated with posaconazole. J Clin Microbiol 2004;42:1376-8. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15004125&query_hl=1&itool=pubmed_DocSum http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=356879&blobtype=pdf Negroni R, Helou SH, Petri N, Robles AM, Arechavala A, Bianchi MH. Case study: posaconazole treatment of disseminated phaeohyphomycosis due to Exophiala spinifera. Clin Infect Dis 2004;38:e15-20. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=14727230&query_hl=1&itool=pubmed_DocSum http://www.journals.uchicago.edu/CID/journal/issues/v38n3/31771/31771.web.pdf Herbrecht R, Letscher-Bru V, Fohrer C, Campos F, Natarajan-Ame S, Zamfir A, et al. Acremonium strictum pulmonary infection in a leukemic patient successfully treated with posaconazole after failure of amphotericin B. Eur J Clin Microbiol Infect Dis 2002;21:814-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12461592&query_hl=1&itool=pubmed_DocSum http://www.springerlink.com/content/mbg0wvqbew24lb6x/fulltext.pdf Sponsel WE, Graybill JR, Nevarez HL, Dang D. Ocular and systemic posaconazole(SCH-56592) treatment of invasive Fusarium solani keratitis and endophthalmitis. Br J Ophthalmol 2002;86:829-30. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12084760&query_hl=1&itool=pubmed_DocSum http://bjo.bmjjournals.com/cgi/reprint/86/7/829-a Mellinghoff IK, Winston DJ, Mukwaya G, Schiller GJ. Treatment of Scedosporium apiospermum brain abscesses with posaconazole. Clin Infect Dis 2002;34:1648-50. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=12032903&query_hl=1&itool=pubmed_DocSum http://www.journals.uchicago.edu/CID/journal/issues/v34n12/011612/011612.web.pdf Company Study Protocol P02952 Protocol P00041 Protocol P02387 Back to Search Results