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”

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.

Study Type: Interventional

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

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: voriconazole
  • Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 200 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 200 mg Q12h).
• Drug: anidulafungin
  • Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: combination 2
  • anidulafungin plus voriconazole
• Experimental: combination 1
  • anidulafungin plus voriconazole

Primary Measures

• The primary endpoint will be global response consisting of a combination of clinical and radiological findings at the end of therapy.
  • Time Frame: up to 6 weeks
    Safety Issue?: No

Secondary Measures

• To assess voriconazole levels with IV and oral dosing
  • Time Frame: Up to 6 weeks
    Safety Issue?: No
• To evaluate mortality and global response at Weeks 2, 4, 6.
  • Time Frame: Up to 6 weeks
    Safety Issue?: Yes
• To evaluate the safety and tolerability of combination therapy with voriconazole and anidulafungin.
  • Time Frame: Up to 6 weeks
    Safety Issue?: Yes
• To compare galactomannan titers (an immunological test performed on blood serum) with the Global Response.
  • Time Frame: Up to 6 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620074

Study ID Number: A8851014

ClinicalTrials.gov Identifier: NCT00620074

Health Authority: United States: Food and Drug Administration

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