Abstract

The objective of this contract is to provide a clinical trial collaborative group accessing the appropriate at-risk populations and providing the expertise to construct and conduct controlled clinical trials addressed the key management problems in serious fungal diseases. The group will be coordinated and evaluated by a coordinating institution. It is expected that the group will: 1) Formulates scientific agenda prioritized according to public health needs for approval by the NIAID; 2) Secure industrial support for patient care and related costs to enable the proposed trials to run to completion; 3) Provide administrative data management and statistical support for development, implementation and analysis of the trials; 4) Provide site monitoring and data and safety quality assurance; and 5) Assess and report progress and results, including summaries and analyses as required by an independent Data and Safety Monitoring Board and for the safety of all studies.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research and Development Contracts (N01)
Project #
N01AI065296-009
Application #
6333343
Study Section
Project Start
1995-10-21
Project End
2000-10-20
Budget Start
2000-04-20
Budget End
2001-03-31
Support Year
Fiscal Year
2000
Total Cost
$1,495,655
Indirect Cost

  Institution

Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294

  Publications

Hadley, S; Huckabee, C; Pappas, P G et al. (2009) Outcomes of antifungal prophylaxis in high-risk liver transplant recipients. Transpl Infect Dis 11:40-8
Dismukes, William E (2006) Antifungal therapy: lessons learned over the past 27 years. Clin Infect Dis 42:1289-96
Wheat, L Joseph; Connolly, Patricia; Smedema, Melinda et al. (2006) Activity of newer triazoles against Histoplasma capsulatum from patients with AIDS who failed fluconazole. J Antimicrob Chemother 57:1235-9
Larsen, Robert A; Pappas, Peter G; Perfect, John et al. (2005) Phase I evaluation of the safety and pharmacokinetics of murine-derived anticryptococcal antibody 18B7 in subjects with treated cryptococcal meningitis. Antimicrob Agents Chemother 49:952-8
van Burik, Jo-Anne H; Ratanatharathorn, Voravit; Stepan, Daniel E et al. (2004) Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation. Clin Infect Dis 39:1407-16
Wheat, L Joseph; Kauffman, Carol A (2003) Histoplasmosis. Infect Dis Clin North Am 17:1-19, vii
Wheat, L Joseph; Connolly, Patricia; Haddad, Nicholas et al. (2002) Antigen clearance during treatment of disseminated histoplasmosis with itraconazole versus fluconazole in patients with AIDS. Antimicrob Agents Chemother 46:248-50
Walsh, Thomas J; Pappas, Peter; Winston, Drew J et al. (2002) Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med 346:225-34
Wheat, L J; Connolly, P; Smedema, M et al. (2001) Emergence of resistance to fluconazole as a cause of failure during treatment of histoplasmosis in patients with acquired immunodeficiency disease syndrome. Clin Infect Dis 33:1910-3
Hajjeh, R A; Pappas, P G; Henderson, H et al. (2001) Multicenter case-control study of risk factors for histoplasmosis in human immunodeficiency virus-infected persons. Clin Infect Dis 32:1215-20

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