Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspergillosis
Intervention: voriconazole (Drug); anidulafungin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This study will test the effectiveness and the safety of giving two antifungal agents
(voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who
are unable to tolerate polyene therapy.
Clinical Details
Official title: Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis Who Are Intolerant of Polyene Treatment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Summary of Global Response at End of Treatment (EOT)
Secondary outcome: Summary of Global Response at Week 2, Week 4, and Week 6Summary of Mortality Galactomannan Titer Assay Levels and Global Response Voriconazole Trough Levels With Intravenous and Oral Dosing
Detailed description:
The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The
decision to terminate the trial was not based on any safety concerns. Patients who were
enrolled in the study prior to January 12, 2009 were allowed to remain in the study until
completing their participation as specified in the protocol.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.
Exclusion Criteria:
Patients with invasive aspergillosis for more than 30 days at the time of study entry.
Patients with uncontrolled bacterial or viral infection at the time of study entry.
Patients with significant liver dysfunction or who are taking certain medications which
interact with voriconazole.
Locations and Contacts
Pfizer Investigational Site, Atlanta, Georgia 30322, United States
Pfizer Investigational Site, Detroit, Michigan 48202, United States
Pfizer Investigational Site, Fort Worth, Texas 76104, United States
Pfizer Investigational Site, Fort Worth, Texas 76107, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2008
Last updated: January 21, 2010
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