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.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00034671
First received: May 1, 2002
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
This phase II study will be conducted to:
- 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
- identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycoses |
Drug: Posaconazole oral suspension |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts |
Resource links provided by NLM:
Further study details as provided by Merck:
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2000 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 13 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00034671 History of Changes |
| Other Study ID Numbers: | P01893 |
| Study First Received: | May 1, 2002 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis Invasive Fungal Infections |
Additional relevant MeSH terms:
|
Mycoses Posaconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013