NCT00620074

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)

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aspergillosis

Interventions

Type	Name	Description
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 300 mg Q12h). Subjects with creatinine clearance \<50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-02-21
• Last updated: 2010-02-15
• Results posted: 2010-02-15

Locations

4 sites across 1 country: United States