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 4

Terminated

Conditions: Aspergillosis

Interventions: Drug: voriconazole
Drug: anidulafungin

Registration Number: NCT00620074

Lead Sponsor: Pfizer

Brief 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combination 2	voriconazole	anidulafungin plus voriconazole
combination 1	anidulafungin	anidulafungin plus voriconazole

Primary Outcome Measures

Name	Time	Method
Summary of Global Response at End of Treatment (EOT)	End of Treatment (Day 42)	Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.

Secondary Outcome Measures

Name	Time	Method
Summary of Global Response at Week 2, Week 4, and Week 6	Week 2, Week 4, Week 6	Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Summary of Mortality	Up to Week 6	Number of subects with documented mortality (death).
Galactomannan Titer Assay Levels and Global Response	Up to Week 6	Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Voriconazole Trough Levels With Intravenous and Oral Dosing	Week 1 through Week 6	Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).