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4. Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

Author

Segal, Brahm H., Herbrecht, Raoul, Stevens, David A., Ostrosky-Zeichner, Luis, Sobel, Jack, Viscoli, Claudio, Walsh, Thomas J., Maertens, Johan, Patterson, Thomas F., Perfect, John R., Dupont, Bertrand, Wingard, John R., Calandra, Thierry, Kauffman, Carol A., Graybill, John R., Baden, Lindsey R., Pappas, Peter G., Bennett, John E., Kontoyiannis, Dimitrios P., Cordonnier, Catherine, Viviani, Maria Anna, Bille, Jacques, Almyroudis, Nikolaos G., Wheat, L. Joseph, Graninger, Wolfgang, Bow, Eric J., Holland, Steven M., Kullberg, Bart-Jan, Dismukes, William E., and De Pauw, Ben E.

Published
2008
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7. Cryptococcus neoformans var. grubii isolates recovered from persons with AIDS demonstrate a wide range of virulence during murine meningoencephalitis that correlates with the expression of certain virulence factors

Author

Clancy, Cornelius J., Nguyen, M. Hong, Alandoerffer, Ruth, Cheng, Shaoji, Iczkowski, Kenneth, Richardson, Malcolm, and Graybill, John R.

Subjects
Drug resistance in microorganisms -- Research, Gene expression -- Research, Virulence (Microbiology) -- Research, Biological sciences
Abstract

Cryptococcus neoformans is a common cause of meningoencephalitis among AIDS patients. Several C. neoformans virulence factors have been identified, but the relative importance of particular factors is unknown. This study examined the corrrelation of the virulence of 18 C. neoformans var. grubii isolates from AIDS patients with the expression of several well-described virulence factors. The L[D.sub.50] at 15 days after intracranial inoculation of ICR mice was < 100 c.f.u. for 22% of isolates, 100-1000 for 28%, 1000-10000 for 11% and >20000 for 39%. Higher cryptococcal concentrations in brains were noted for isolates with lower L[D.sub.50] (P = 0.002). In survival studies, no immunocompetent BALB/c mice (nul-) infected with 3 x L[D.sub.50] of three virulent isolates (L[D.sub.50] = 62, 99, 1280) survived beyond 23 days, whereas 100 %, 90 % and 90 % of mice infected with 20 000 c.f.u, of three hypovirulent isolates (L[D.sub.50] > 20 000) survived for 60 days (P

Published
2006

8. Safety of long-term oral posaconazole use in the treatment of refractory invasive fungal infections

Author

Raad, Issam I., Graybill, John R., Bustamante, Ana Beatriz, Cornely, Oliver A., Gaona-Flores, Veronica, Afif, Claude, Graham, Donald R., Greenberg, Richard N., Hadley, Susan, Langston, Amelia, Negroni, Ricardo, Perfect, John R., Pitisuttithum, Punnee, Restrepo, Angela, Schiller, Gary, Pedicone, Lisa, and Ullmann, Andrew J.

Subjects
Triazoles -- Dosage and administration, Triazoles -- Research, Mycoses -- Drug therapy, Neutropenia -- Drug therapy, Health, Health care industry
Published
2006

10. Refractory coccidioidomycosis treated with posaconazole

Author

Anstead, Gregory M., Corcoran, Gavin, Lewis, James, Berg, Deborah, and Graybill, John R.

Subjects
Mycoses -- Drug therapy, Coccidioidomycosis -- Genetic aspects, Coccidioidomycosis -- Drug therapy, Health, Health care industry, Posaconazole (Medication) -- Dosage and administration
Published
2005

11. Histoplasmosis in the acquired immunodeficiency syndrome (AIDS): treatment with itraconazole and fluconazole

Author

Sharkey-Mathis, Patricia Kay, Velez, Juan, Fetchick, Richard, and Graybill, John R.

Subjects
Histoplasmosis -- Drug therapy, Itraconazole -- Health aspects, Fluconazole -- Health aspects, AIDS (Disease) -- Complications, Health
Abstract

Itraconazole may be more effective than fluconazole for the treatment of histoplasmosis in AIDS patients. Histoplasmosis is an infection caused by inhaling the spores of the fungus Histoplasma. Among 20 AIDS patients with histoplasmosis, 12 took 400 milligrams (mg) of itraconazole per day and 10 took between 100 and 800 mg of fluconazole per day. Two patients treated with itraconazole had initially been treated unsuccessfully with 100 mg per day of fluconazole. Seven patients treated with itraconazole went into remission, two improved and three did not respond to treatment. Three patients treated with fluconazole went into remission, one improved and six failed to respond to treatment. No significant difference in response to treatment occurred between the patients treated with high-dose and low-dosage fluconazole.

Published
1993

18. Clinical research in the lay press: irresponsible journalism raises a huge dose of doubt

Author

Anaissie, Elias J., Segal, Brahm H., Graybill, John R., Arndt, Carola, Perfect, John R., Kleinberg, Michael, Pappas, Peter, Benjamin, Danny, Rubin, Robert, Aberg, Judith A., Adderson, Elisabeth E., Adler-Shohet, Felice C., Akan, Hamdi, Akova, Murat, Almyroudis, Nikolaos G., Alexander, Barbara D., Andes, David, Arrieta, Antonio, Baddley, John W., Barron, Michelle A., Belzberg, Howard, Boucher, Helen W., Boyce, Thomas G., Casadevall, Arturo, Chandrasekar, P.H., Cleary, John D., Cordonnier, Catherine, Cornely, Oliver A., Cuenca-Estrella, Manuel, Daly, Jennifer S., Daoura, Nicholas, Denning, David W., dePauw, Ben, Repentigny, Louis de, Dignani, Maria Cecilia, Dismukes, William E., Donnelly, J. Peter, Donowitz, Gerald R., Dupont, Bertrand, Drusano, George, Ellis, Michael, Espinel-Ingroff, Ana, Fishman, Jay A., Fleming, Rhonda, Forrest, Graeme, Ghannoum, Mahmoud, Goldman, Mitchell, Grazziutti, Monica, Greene, John N., Greenberg, Richard N., Gubbins, Paul O., Hadley, Susan, Herbrecht, Raoul, Hiemenz, John W., Hope, William, Hospenthal, Durane R., Husain, Shahid, Ito, James I., Jacobson, Robert M., Johnson, Melissa, Keating, Michael R., Kett, Daniel H., Knapp, Katherine, Kontoyiannis, Dimitrios P., Krcmery, Vladimir C., Larsen, Robert, Laverdiere, Michel, Ljungman, Per, Lortholary, O., Maertens, Johan, Marriott, Debbie, Mattiuzzi, Gloria, McGinnis, Michael R., Morris, Michele, Nucci, Marcio, Odds, Frank C., Pankey, George A., Patterson, Thomas, Pfaller, Mike, Razonable, Raymond R., Reboli, Annette C., Rinaldi, Michael G., Roberts, Glenn D., Tudela, Juan Luis Rodriguez, Rotstein, Coleman, Ruhnke, Markus, Schuster, Mindy, Shoham, Shmuel, Sia, Irene G., Siebel, Nita, Silviera, Fernanda, Singh, Nina, Sobel, Jack, Solomkin, Joseph S., Sorrell, Tania C., Steinbach, William J., Temesgen, Zelalem, Tortorano, AnnaMaria, Vartivarian, Shahe, VerWeij, Paul, Viscoli, Claudio, Viviani, Maria Anna, Walker, Randall C., Wheat, Joseph L., Wiley, Joseph, Williamson, Peter, Wingard, John R., Yu, Victor L., and Zaoutis, Theoklis

Subjects
Clinical trials -- Evaluation, Journalism, Medical -- Evaluation, Health, Health care industry
Published
2006

19. Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

Author

Segal, Brahm H., Herbrecht, Raoul, Stevens, David A., Ostrosky-Zeichner, Luis, Sobel, Jack, Viscoli, Claudio, Walsh, Thomas J., Maertens, Johan, Patterson, Thomas F., Perfect, John R., Dupont, Bertrand, Wingard, John R., Calandra, Thierry, Kauffman, Carol A., Graybill, John R., Baden, Lindsey R., Pappas, Peter G., Bennett, John E., Kontoyiannis, Dimitrios P., Cordonnier, Catherine, Viviani, Maria Anna, Bille, Jacques, Almyroudis, Nikolaos G., Wheat, L. Joseph, Graninger, Wolfgang, Bow, Eric J., Holland, Steven M., Kullberg, Bart-Jan, Dismukes, William E., De Pauw, Ben E., Segal, Brahm H., Herbrecht, Raoul, Stevens, David A., Ostrosky-Zeichner, Luis, Sobel, Jack, Viscoli, Claudio, Walsh, Thomas J., Maertens, Johan, Patterson, Thomas F., Perfect, John R., Dupont, Bertrand, Wingard, John R., Calandra, Thierry, Kauffman, Carol A., Graybill, John R., Baden, Lindsey R., Pappas, Peter G., Bennett, John E., Kontoyiannis, Dimitrios P., Cordonnier, Catherine, Viviani, Maria Anna, Bille, Jacques, Almyroudis, Nikolaos G., Wheat, L. Joseph, Graninger, Wolfgang, Bow, Eric J., Holland, Steven M., Kullberg, Bart-Jan, Dismukes, William E., and De Pauw, Ben E.

Abstract

Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge

Published
2017

21. NIAID mycoses study group multicenter trial of oral itraconazole therapy for invasive aspergillosis

Author

California Institute of Medical Research, San Jose, USA, Denning, David W., Lee, Jeanette Y., Hostetler, John S., Pappas, Peter, Kauffman, Carol A., Dewsnup, Daniel H., Galgiani, John N., Graybill, John R., Sugar, Alan M., Catanzaro, Antonino, California Institute of Medical Research, San Jose, USA, Denning, David W., Lee, Jeanette Y., Hostetler, John S., Pappas, Peter, Kauffman, Carol A., Dewsnup, Daniel H., Galgiani, John N., Graybill, John R., Sugar, Alan M., and Catanzaro, Antonino

Abstract

Invasive aspergillosis is the most common invasive mould infection and a major cause of mortality in immunocompromised patients. Response to amphotericin B, the only antifungal agent licensed in the United States for the treatment of aspergillosis, is suboptimal. A multicenter open study with strict entry criteria for invasive aspergillosis evaluated oral itraconazole (600 mg/d for 4 days followed by 400 mg/d) in patients with various underlying conditions. Response was based on clinical and radiologic criteria plus microbiology, histopathology, and autopsy data. Responses were categorized as complete, partial, or stable. Failure was categorized as an itraconazole failure or overall failure. Our study population consisted of 76 evaluable patients. Therapy duration varied from 0.3 to 97 weeks (median 46). At the end of treatment, 30 (39%) patients had a complete or partial response, and 3 (4%) had a stable response, and in 20 patients (26%), the protocol therapy was discontinued early (at 0.6 to 54.3 weeks) because of a worsening clinical course or death due to aspergillosis (itraconazole failure). Twenty-three (30%) patients withdrew for other reasons including possible toxicity (7%) and death due to another cause but without resolution of aspergillosis (20%). Itraconazole failure rates varied widely according to site of disease and underlying disease group: 14% for pulmonary and tracheobronchial disease, 50% for sinus disease, 63% for central nervous system disease, and 44% for other sites; 7% in solid organ transplant, 29% in allogeneic bone marrow transplant patients, and 14% in those with prolonged granulocytopenia (median 19 days), 44% in AIDS patients, and 32% in other host groups. The relapse rates among those who completed therapy and those who discontinued early for possible toxicity were 12% and 40%, respectively; all were still immunosuppressed. Oral itraconazole is a useful alternative therapy for invasive aspergillosis with response rates apparently com

Published
2006

22. Treatment of sporotrichosis with itraconazole

Author

Department of Veterans Affairs Medical Center and University of Michigan Medical School, Ann Arbor, Michigan, USA, Audie L. Murphy Memorial Veterans Hospital and University of Texas Health Science Center, San Antonio, Texas, USA, Santa Clara Valley Medical Center and Stanford University Medical School, San Jose, California, USA, University of Alabama at Birmingham, Birmingham, Alabama, USA, University of Alabama at Birmingham, Birmingham, Alabama, USA; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA., Sharkey-Mathis, Patricia Kay, Kauffman, Carol A., Graybill, John R., Stevens, David A., Hostetler, John S., Cloud, Gretchen, Dismukes, William E., Department of Veterans Affairs Medical Center and University of Michigan Medical School, Ann Arbor, Michigan, USA, Audie L. Murphy Memorial Veterans Hospital and University of Texas Health Science Center, San Antonio, Texas, USA, Santa Clara Valley Medical Center and Stanford University Medical School, San Jose, California, USA, University of Alabama at Birmingham, Birmingham, Alabama, USA, University of Alabama at Birmingham, Birmingham, Alabama, USA; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA., Sharkey-Mathis, Patricia Kay, Kauffman, Carol A., Graybill, John R., Stevens, David A., Hostetler, John S., Cloud, Gretchen, and Dismukes, William E.

Abstract

To describe the clinical presentation and outcomes of treatment with itraconazole in patients with sporotrichosis. A culture for Sporothrix schenckii or compatible histopathology was required for inclusion in the study. Patients with both cutaneous and systemic sporotrichosis were treated. Patients received from 100 to 600 mg of itraconazole daily for 3 to 18 months. Patients were classified as responders or nonresponders. Responders were further classified as remaining on treatment, relapsed, or free of disease. Nonresponders included patients who failed to respond or progressed during treatment with itraconazole. Twenty-seven patients (mean age: 53 years) were treated with 30 courses of itraconazole. Diabetes mellitus and alcoholism were present in eight and seven patients, respectively. Sites of involvement included lymphocutaneous alone in 9 patients, articular/osseous in 15 (multifocal in 3), and lung in 3. Prior therapy was unsuccessful in 11 patients. Among the 30 courses, there were 25 responders and 5 nonresponders. All 5 nonresponders received at least 200 mg daily of itraconazole for durations that ranged from 6 to 18 months. Of the 25 responders, 7 relapsed 1 to 7 months after treatment durations of 6 to 18 months. Of the 7 who relapsed, 2 are responding to a second course. One responder was lost to follow-up after 10 months of treatment with itraconazole. Of the remaining 17 responders, 3 remain on treatment, and 14 are free of disease over follow-up durations of 6 to 42 months (mean: 17.6 months). Itraconazole was well tolerated with few side effects noted. These results document the efficacy of itraconazole in the treatment of cutaneous and systemic sporotrichosis.

Published
2006

25. Inhaled Voriconazole for Prevention of Invasive Pulmonary Aspergillosis

Author

Tolman, Justin A., primary, Wiederhold, Nathan P., additional, McConville, Jason T., additional, Najvar, Laura K., additional, Bocanegra, Rosie, additional, Peters, Jay I., additional, Coalson, Jacqueline J., additional, Graybill, John R., additional, Patterson, Thomas F., additional, and Williams, Robert O., additional

Published
2009
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26. Assessment of Aspergillus fumigatus Burden in Pulmonary Tissue of Guinea Pigs by Quantitative PCR, Galactomannan Enzyme Immunoassay, and Quantitative Culture

Author

Vallor, Ana C., primary, Kirkpatrick, William R., additional, Najvar, Laura K., additional, Bocanegra, Rosie, additional, Kinney, Marsha C., additional, Fothergill, Annette W., additional, Herrera, Monica L., additional, Wickes, Brian L., additional, Graybill, John R., additional, and Patterson, Thomas F., additional

Published
2008
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30. Reply to Tattevin et al

Author

Anstead, Gregory and Graybill, John R.

Subjects
AIDS (Disease) -- Diagnosis, Illegal immigrants -- Health aspects, HIV infection -- Diagnosis, Health, Health care industry
Published
2005

33. Disruption of a Nonribosomal Peptide Synthetase in Aspergillus fumigatus Eliminates Gliotoxin Production

Author

Cramer, Robert A., primary, Gamcsik, Michael P., additional, Brooking, Rhea M., additional, Najvar, Laura K., additional, Kirkpatrick, William R., additional, Patterson, Thomas F., additional, Balibar, Carl J., additional, Graybill, John R., additional, Perfect, John R., additional, Abraham, Soman N., additional, and Steinbach, William J., additional

Published
2006
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34. In Vivo Efficacy of Aerosolized Nanostructured ItraconazoleFormulations for Prevention of Invasive Pulmonary Aspergillosis

Author

Hoeben, Barbara J., primary, Burgess, David S., additional, McConville, Jason T., additional, Najvar, Laura K., additional, Talbert, Robert L., additional, Peters, Jay I., additional, Wiederhold, Nathan P., additional, Frei, Bradi L., additional, Graybill, John R., additional, Bocanegra, Rosie, additional, Overhoff, Kirk A., additional, Sinswat, Prapasri, additional, Johnston, Keith P., additional, and Williams, Robert O., additional

Published
2006
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