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Original Research |

Treatment of Blastomycosis and Histoplasmosis with Ketoconazole: Results of a Prospective Randomized Clinical Trial

[+] Article, Author, and Disclosure Information

Grant support: in part by contract N01 AI 82570 with the Clinical and Epidemiological Studies Branch, Microbiology and Infectious Diseases Program, National Institute of Allergy and Infectious Diseases; by grant DRR RR32 to the Clinical Research Center, University of Alabama at Birmingham; by grant CA 13148 to the Comprehensive Cancer Center, University of Alabama at Birmingham; by grant RR00036 to the Clinical Research Center, Washington University School of Medicine.

▸Requests for reprints should be addressed to William E. Dismukes, M.D.; Division of Infectious Diseases, Suite 229, THT, University of Alabama School of Medicine, University Station; Birmingham, AL 35294.

▸From the Division of Infectious Diseases, Department of Medicine, and the Department of Biostatistics, University of Alabama School of Medicine at Birmingham, Birmingham, Alabama; and the National Institutes of Health, Bethesda, Maryland.*Members of the National Institute of Allergy and Infectious Diseases Mycoses Study Group include William E. Dismukes, M.D.; Gretchen Cloud, M.S.; Cynthia Bowles, R.N.; George A. Sarosi, M.D.; Clark R. Gregg, M.D.; Stanley W. Chapman, M.D.; W. Michael Scheid, M.D.; Barry Farr, M.D.; Harry A. Gallis, M.D.; Robert L. Marier, M.D.; George H. Karam, M.D.; John E. Bennett, M.D.; Carol A. Kauffman, M.D.; Gerald Medoff, M.D.; David A. Stevens, M.D.; Lisa G. Kaplowitz, M.D.; John R. Black, M.D.; Gary A. Roselle, M.D.; George A. Pankey, M.D.; Thomas M. Kerkering, M.D.; John F. Fisher, M.D.; John R. Graybill, M.D.; and Smith Shadomy, Ph.D.

Birmingham, Alabama; and Bethesda, Maryland

©1985 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1985;103(6_Part_1):861-872. doi:10.7326/0003-4819-103-6-861
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In a multicenter prospective randomized trial, the efficacy and toxicity of low-dose (400 mg/d) and high-dose (800 mg/d) oral ketoconazole were compared in 80 patients with blastomycosis and in 54 with histoplasmosis. Among 65 patients with blastomycosis treated for 6 months or more, high-dose treatment was more effective (100% success rate compared with 79%;p = 0.001). Among 19 patients with chronic cavitary histoplasmosis treated for 6 months or more, both regimens were equally effective (overall success rate, 84%). In 20 patients with localized or disseminated histoplasmosis treated for 6 months or more, low-dose treatment was more effective (100% success rate compared with 57%;p = 0.03). The success rate for all patients with histoplasmosis treated for 6 months or more was 85%. Adverse effects occurred in 81 of 134 patients (60%) and were commoner with the high-dose regimen. Ketoconazole is effective for immunocompetent patients with non-life-threatening, nonmeningeal forms of blastomycosis and histoplasmosis. Because of the higher frequency of side effects associated with the high dose, ketoconazole therapy should be initiated with the low dose.





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