Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Phase 3
Completed
- Conditions
- Health Condition 1: null- Aspergillosis
- Registration Number
- CTRI/2009/091/000387
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 455
Inclusion Criteria
Ages Eligible for Study: 16 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
1. Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
2.Diagnosis of possible, probable, or proven invasive aspergillosis.
Exclusion Criteria
1.Patients with aspergilloma or chronic aspergillosis
2.Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
3.Anticipated survival of less than 5 days or Karnofsky score <=20
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is all cause mortality, measured 6 weeks after IA initiation of study drug in subjects with proven or probable IATimepoint: 6 weeks after IA initiation
- Secondary Outcome Measures
Name Time Method All cause mortality at 12 weeks in subjects with probable or proven IATimepoint: All cause mortality at 12 weeks;All cause mortality at 6 weeks in subjects with possible, probable, or proven IATimepoint: All cause mortality at 6 weeks;Mortality due to IA at 6 weeksTimepoint: at 6 weeks;Rate of global response at 6 weeksTimepoint: at 6 weeks;Safety and tolerability of voriconazole monotherapy compared to that of voriconazole in combination with anidulafunginTimepoint: Duration of trial;Time to death (all cause mortality)Timepoint: Time to death (all cause mortality)