Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Tracking Information| Start Date ICMJE | May 2008 |
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| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: January 23, 2008) | The primary endpoint is all cause mortality, measured 6 weeks after IA initiation of study drug in subjects with proven or probable IA. [ Time Frame: 6 weeks after IA initiation ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE
(submitted: September 14, 2007) | The primary endpoint is all cause mortality, measured 6 weeks after IA diagnosis in subjects with proven or probable IA. |
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| Change History | Complete list of historical versions of study NCT00531479 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: May 6, 2008) | - Rate of global response at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
- All cause mortality at 6 weeks in subjects with possible, probable, or proven IA [ Time Frame: All cause mortality at 6 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of voriconazole monotherapy compared to that of voriconazole in combination with anidulafungin [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- All cause mortality at 12 weeks in subjects with probable or proven IA [ Time Frame: All cause mortality at 12 weeks ] [ Designated as safety issue: No ]
- Mortality due to IA at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
- Time to death (all cause mortality) [ Time Frame: Time to death (all cause mortality) ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE
(submitted: September 14, 2007) | - Rate of global response at 6 weeks
- All cause mortality at 12 weeks
- Time to death (all cause mortality)
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Descriptive Information| Brief Title ICMJE | Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis |
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| Official Title ICMJE | A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis |
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| Brief Summary | This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis. |
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | Aspergillosis |
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| Intervention ICMJE | - Drug: voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Other Name: Vfend - Drug: anidulafungin
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Other Name: Eraxis - Drug: voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Other Name: Vfend
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| Study Arms / Comparison Groups | |
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Recruitment Information| Estimated Enrollment ICMJE | 405 |
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| Estimated Completion Date | September 2011 |
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| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
- Diagnosis of possible, probable, or proven invasive aspergillosis.
Exclusion Criteria: - Patients with aspergilloma or chronic aspergillosis
- Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
- Anticipated survival of less than 5 days or Karnofsky score <=20
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| Gender | Both |
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| Ages | 16 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
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| Location Countries ICMJE | United States, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, India, Italy, Korea, Republic of, Netherlands, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00531479 |
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| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
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| Study ID Numbers ICMJE | A8851009 |
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| Study Sponsor ICMJE | Pfizer |
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| Collaborators ICMJE | Mycoses Study Group |
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| Investigators ICMJE | | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
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| Information Provided By | Pfizer |
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