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)
This study has been terminated.
(See Detailed Description)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00620074
First received: February 8, 2008
Last updated: January 21, 2010
Last verified: January 2010
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Summary of Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 42) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Summary of Global Response at Week 2, Week 4, and Week 6 [ Time Frame: Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
- Summary of Mortality [ Time Frame: Up to Week 6 ] [ Designated as safety issue: Yes ]
- Galactomannan Titer Assay Levels and Global Response [ Time Frame: Up to Week 6 ] [ Designated as safety issue: No ]
- Voriconazole Trough Levels With Intravenous and Oral Dosing [ Time Frame: Week 1 through Week 6 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: combination 2
anidulafungin plus voriconazole
|
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).
Other Name: Vfend
|
|
Experimental: combination 1
anidulafungin plus voriconazole
|
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
Other Name: Eraxis
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620074
Locations
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00620074 History of Changes |
| Other Study ID Numbers: | A8851014 |
| Study First Received: | February 8, 2008 |
| Results First Received: | January 21, 2010 |
| Last Updated: | January 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
invasive aspergillosis, opportunistic mold infection |
Additional relevant MeSH terms:
|
Aspergillosis Mycoses Voriconazole Anidulafungin Echinocandins Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013