PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)
Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts
1 other identifier
interventional
98
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2001
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 1, 2002
CompletedFirst Posted
Study publicly available on registry
May 2, 2002
CompletedDecember 31, 2015
December 1, 2015
10 months
May 1, 2002
December 30, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ullmann AJ, Cornely OA, Burchardt A, Hachem R, Kontoyiannis DP, Topelt K, Courtney R, Wexler D, Krishna G, Martinho M, Corcoran G, Raad I. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob Agents Chemother. 2006 Feb;50(2):658-66. doi: 10.1128/AAC.50.2.658-666.2006.
PMID: 16436724RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2002
First Posted
May 2, 2002
Study Start
January 1, 2001
Primary Completion
November 1, 2001
Study Completion
March 1, 2002
Last Updated
December 31, 2015
Record last verified: 2015-12