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).

Condition(s) targeted: Aspergillosis

Intervention: voriconazole (Drug); anidulafungin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint will be global response consisting of a combination of clinical and radiological findings at the end of therapy.

Secondary outcome:

To assess voriconazole levels with IV and oral dosing

To evaluate mortality and global response at Weeks 2, 4, 6.

To evaluate the safety and tolerability of combination therapy with voriconazole and anidulafungin.

To compare galctomannan titers (an immunological test performed on blood serum) with the Global Response.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Recruiting

Pfizer Investigational Site, Sacramento, California 95817, United States; Not yet recruiting

Pfizer Investigational Site, Aurora, Colorado 80045, United States; Not yet recruiting

Pfizer Investigational Site, Newark, Delaware 19718, United States; Not yet recruiting

Pfizer Investigational Site, Atlanta, Georgia 30322, United States; Recruiting

Pfizer Investigational Site, Detroit, Michigan 48202, United States; Not yet recruiting

Pfizer Investigational Site, Minneapolis, Minnesota 55455, United States; Recruiting

Pfizer Investigational Site, Albany, New York 12208, United States; Not yet recruiting

Pfizer Investigational Site, Hamilton, Ontario L8L 2X2, Canada; Recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada; Recruiting

Pfizer Investigational Site, Hamilton, Ontario L8V 1C3, Canada; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States; Not yet recruiting

Pfizer Investigational Site, Québec, Quebec G1R 2J6, Canada; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38104, United States; Recruiting

Pfizer Investigational Site, Fort Worth, Texas 76104, United States; Recruiting

Pfizer Investigational Site, Fort Worth, Texas 76107, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75246, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: August 2008
Ending date: April 2010
Last updated: October 31, 2008