This phase II study will be conducted to: 1) evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and 2) identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.

Condition	Treatment or Intervention	Phase
Mycoses	Drug: Posaconazole oral suspension	Phase II

Further Study Details: 

Expected Total Enrollment:  100

This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.

The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.

Ages Eligible for Study:  13 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• A proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies.
• Subjects who received >72 hours of systemic empiric antibacterial therapy and are neutropenic (<500 neutrophils per mm3 and, have had fever that has reached an oral temperature >38c (or >100.4f)twice in the last 48 hours, or have a recurrence of fever (oral temperature, >38c or >100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.
• Able to take oral medication or take medication via enteral feeding tube.

Colorado
      Anschutz Cancer Pavilion, Denver,  Colorado,  United States
      University of Colorado, Denver,  Colorado,  United States
Florida
      University of Florida, Miami,  Florida,  United States
Illinois
      University of Illinois at Chicago, Chicago,  Illinois,  United States
New York
      Albany Medical College, Albany,  New York,  United States
North Carolina
      Duke University, Durham,  North Carolina,  United States
Oregon
      Oregon Health Sciences University, -----,  Oregon,  United States
Texas
      UT MDACC, Houston,  Texas,  United States
      University of Texas, San Antonio,  Texas,  United States
Wisconsin
      Medical College of Wisconsin BMT program, Milwaukee,  Wisconsin,  United States
Germany, Frankfurt
      Klinikum der Johannes Gutenberg - Universitaet Mainz, Frankfrut,  Frankfurt,  Germany

Study ID Numbers:  P01893
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  May 1, 2002
ClinicalTrials.gov Identifier:  NCT00034671
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08