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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00620074 |
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.
Condition | Intervention | Phase |
---|---|---|
Aspergillosis |
Drug: voriconazole Drug: anidulafungin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 6 |
Study Start Date: | August 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
combination 2: Experimental
anidulafungin plus voriconazole
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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).
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combination 1: Experimental
anidulafungin plus voriconazole
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | 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.
United States, Georgia | |
Pfizer Investigational Site | |
Atlanta, Georgia, United States, 30322 | |
United States, Michigan | |
Pfizer Investigational Site | |
Detroit, Michigan, United States, 48202 | |
United States, Texas | |
Pfizer Investigational Site | |
Fort Worth, Texas, United States, 76104 | |
Pfizer Investigational Site | |
Fort Worth, Texas, United States, 76107 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8851014 |
Study First Received: | February 8, 2008 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00620074 History of Changes |
Health Authority: | United States: Food and Drug Administration |
invasive aspergillosis, opportunistic mold infection |
Anti-Bacterial Agents Mycoses Clotrimazole Miconazole Antifungal Agents |
Voriconazole Tioconazole Aspergillosis Anidulafungin |
Anti-Infective Agents Mycoses Therapeutic Uses Antifungal Agents Voriconazole |
Antibiotics, Antifungal Aspergillosis Pharmacologic Actions Anidulafungin |