- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
January 21, 2010 updated by: Pfizer
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Pfizer Investigational Site
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Michigan
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Detroit, Michigan, United States, 48202
- Pfizer Investigational Site
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Texas
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Fort Worth, Texas, United States, 76104
- Pfizer Investigational Site
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Fort Worth, Texas, United States, 76107
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: combination 2
anidulafungin plus 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).
Other Names:
|
Experimental: combination 1
anidulafungin plus voriconazole
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Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of Global Response at End of Treatment (EOT)
Time Frame: 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.
|
End of Treatment (Day 42)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of Global Response at Week 2, Week 4, and Week 6
Time Frame: 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.
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Week 2, Week 4, Week 6
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Summary of Mortality
Time Frame: Up to Week 6
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Number of subects with documented mortality (death).
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Up to Week 6
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Galactomannan Titer Assay Levels and Global Response
Time Frame: Up to Week 6
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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.
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Up to Week 6
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Voriconazole Trough Levels With Intravenous and Oral Dosing
Time Frame: Week 1 through Week 6
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Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).
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Week 1 through Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
February 8, 2008
First Submitted That Met QC Criteria
February 20, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
February 15, 2010
Last Update Submitted That Met QC Criteria
January 21, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Aspergillosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Anidulafungin
- Voriconazole
Other Study ID Numbers
- A8851014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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