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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections Clinical research trials and PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections. PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections clinical trial. Human subjects frequently get the finest healthcare available for their PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections  PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
For Condition: Mycoses
Status: Recruiting
Sponsor(s): Schering-Plough ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Albany Medical College *Recruiting*
Albany, New York,
United States
Recruiting Arnold Louie 518-262-5343
University of Texas *Recruiting*
San Antonio, Texas,
United States
Recruiting J Graybill 210-617-5111
Duke University *Terminated*
Durham, North Carolina,
United States
Terminated
University of Illinois at Chicago *Recruiting*
Chicago, Illinois,
United States
Recruiting Steven Devine 312-413-2655
Medical College of Wisconsin BMT program *Recruiting*
Milwaukee, Wisconsin,
United States
Recruiting David Vesole 414-257-7142
Klinikum der Johannes Gutenberg - Universitaet Mainz *Completed*
Frankfrut, Frankfurt,
Germany
Completed
Anschutz Cancer Pavilion *Recruiting*
Denver, Colorado,
United States
Recruiting Gail Eckhardt 702-848-0668
UT MDACC *Completed*
Houston, Texas,
United States
Completed
University of Colorado *Completed*
Denver, Colorado,
United States
Completed
Oregon Health Sciences University *Terminated*
, Oregon,
United States
Terminated
University of Florida *No longer recruiting*
Miami, Florida,
United States
No longer recruiting
Additional Information:
Study ID Numbers: P01893;
Study Start Date: October 2000
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034671
Other Mycoses Studies:
1. A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children with New Onset Fever and Neutropenia
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
3. PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
4. Voriconazole to Prevent Systemic Fungal Infections in Children
5. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections
Related Studies:
Other Mycoses Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections
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