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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 6

Summary 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

Page last updated: August 23, 2015

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