Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00531479
• Date of registration: 14/09/2007
• Primary sponsor: Pfizer
• Public title: Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
• Scientific title: 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
• Date of first enrolment: July 2008
• Target sample size: 459
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00531479
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, Austria, 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, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aspergillosis

Intervention(s)

Drug: anidulafungin

Drug: voriconazole

Primary Outcome(s)

All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis [Time Frame: Day 1 to Day 42 (Week 6)]

Secondary Outcome(s)

All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA) [Time Frame: Day 1 to Day 84 (Week 12)]

All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA) [Time Frame: Day 1 to Day 42 (Week 6)]

Global Response at Week 6 [Time Frame: Baseline, Day 42 (Week 6)]

Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA [Time Frame: Day 1 to Day 42 (Week 6)]

Time to Death Due to Invasive Aspergillosis (IA) [Time Frame: Day 1 to Day 84 (Week 12)]

Time to Death: All-Cause Mortality [Time Frame: Day 1 to Day 84 (Week 12)]

Secondary ID(s)

A8851009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors