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)

NCT00620074 | Terminated Phase 4 Results DMC

• 1 other identifier: A8851014
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

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.

Conditions

Aspergillosis

Keywords

invasive aspergillosis, opportunistic mold infection

Outcome Measures

Primary Outcomes (1)

• Summary of Global Response at End of Treatment (EOT)

  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.

  End of Treatment (Day 42)

Secondary Outcomes (4)

• Summary of Global Response at Week 2, Week 4, and Week 6

  Week 2, Week 4, Week 6

• Summary of Mortality

  Up to Week 6

• Galactomannan Titer Assay Levels and Global Response

  Up to Week 6

• Voriconazole Trough Levels With Intravenous and Oral Dosing

  Week 1 through Week 6

Study Arms (2)

combination 2

EXPERIMENTAL

anidulafungin plus voriconazole

Drug: voriconazole

combination 1

EXPERIMENTAL

anidulafungin plus voriconazole

Drug: anidulafungin

Interventions

voriconazole DRUG

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).

Also known as: Vfend

combination 2

anidulafungin DRUG

Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Also known as: Eraxis

combination 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Fort Worth, Texas, 76104, United States

Location

Pfizer Investigational Site

Fort Worth, Texas, 76107, United States

Location

Related Links

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

MeSH Terms

Conditions

Aspergillosis

Interventions

Voriconazole; Anidulafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Due to low enrollment and early termination of the study, data was insufficient for descriptive or inferential analysis as planned; no significant treatment-related safety results were identified in the subjects treated with combination therapy.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 15, 2010
• Results First Posted: February 15, 2010

Record last verified: 2010-01

Locations

US (4)