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PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)(COMPLETED)
This study has been completed.
Study NCT00034671   Information provided by Schering-Plough
First Received: May 1, 2002   Last Updated: May 31, 2006   History of Changes

May 1, 2002
May 31, 2006
October 2000
 
 
 
Complete list of historical versions of study NCT00034671 on ClinicalTrials.gov Archive Site
 
 
 
PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)(COMPLETED)
Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Mycoses
Drug: Posaconazole oral suspension
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
100
 
 

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.
Both
13 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00034671
 
P01893
Schering-Plough
 
 
Schering-Plough
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP