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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aspergillosis

Intervention: voriconazole (Drug); anidulafungin (Drug); voriconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis

Secondary outcome:

Global Response at Week 6

All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)

All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)

Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA

Time to Death: All-Cause Mortality

Time to Death Due to Invasive Aspergillosis (IA)

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Brugge 8000, Belgium

Pfizer Investigational Site, Bruxelles 1000, Belgium

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Yvoir B-5530, Belgium

Pfizer Investigational Site, Quebec G1R 2J6, Canada

Pfizer Investigational Site, Praha 2 128 20, Czech Republic

Pfizer Investigational Site, Brest 29609, France

Pfizer Investigational Site, Creteil 94010, France

Pfizer Investigational Site, GRENOBLE Cedex 09 38043, France

Pfizer Investigational Site, Paris 75475, France

Pfizer Investigational Site, Rouen Cedex 76038, France

Pfizer Investigational Site, Strasbourg 67098, France

Pfizer Investigational Site, Berlin 10117, Germany

Pfizer Investigational Site, Berlin 12200, Germany

Pfizer Investigational Site, Bremen 28177, Germany

Pfizer Investigational Site, Dresden 01307, Germany

Pfizer Investigational Site, Frankfurt (Oder) 15236, Germany

Pfizer Investigational Site, Hamburg 20246, Germany

Pfizer Investigational Site, Heidelberg 69120, Germany

Pfizer Investigational Site, Homburg/Saar 66421, Germany

Pfizer Investigational Site, Koeln 50937, Germany

Pfizer Investigational Site, Mainz 55101, Germany

Pfizer Investigational Site, Muenchen 81737, Germany

Pfizer Investigational Site, Wuerzburg 97080, Germany

Pfizer Investigational Site, Thessaloniki 57010, Greece

Pfizer Investigational Site, Cuneo 12100, Italy

Pfizer Investigational Site, Genova 16132, Italy

Pfizer Investigational Site, Milano 20132, Italy

Pfizer Investigational Site, Milano 20162, Italy

Pfizer Investigational Site, Perugia 06134, Italy

Pfizer Investigational Site, Pescara 65100, Italy

Pfizer Investigational Site, Roma 00168, Italy

Pfizer Investigational Site, Seoul 150-713, Korea, Republic of

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of

Pfizer Investigational Site, RC Leiden NL-2300, Netherlands

Pfizer Investigational Site, Lima Lima 34, Peru

Pfizer Investigational Site, Gdansk 80-952, Poland

Pfizer Investigational Site, Warszawa 02-097, Poland

Pfizer Investigational Site, Lisboa 1169-050, Portugal

Pfizer Investigational Site, Lisboa 1649-035, Portugal

Pfizer Investigational Site, Moscow 115478, Russian Federation

Pfizer Investigational Site, Moscow 125167, Russian Federation

Pfizer Investigational Site, Moscow 105229, Russian Federation

Pfizer Investigational Site, Saint Petersburg 197089, Russian Federation

Pfizer Investigational Site, Singapore 169608, Singapore

Pfizer Investigational Site, Singapore 119074, Singapore

Pfizer Investigational Site, Madrid 28006, Spain

Pfizer Investigational Site, Madrid 28050, Spain

Pfizer Investigational Site, Salamanca 37007, Spain

Pfizer Investigational Site, Valencia 46010, Spain

Pfizer Investigational Site, Valencia 46026, Spain

Pfizer Investigational Site, Geneve 14 CH-1211, Switzerland

Pfizer Investigational Site, Lausanne 1011, Switzerland

Pfizer Investigational Site, Kaohsiung 807, Taiwan

Pfizer Investigational Site, Taipei 112, Taiwan

Pfizer Investigational Site, Bangkok 10700, Thailand

Pfizer Investigational Site, Bangkok 10330, Thailand

Pfizer Investigational Site, Bangkok 10400, Thailand

Pfizer Investigational Site, Adana 01330, Turkey

Pfizer Investigational Site, Ankara 06100, Turkey

Pfizer Investigational Site, London SE5 9RS, United Kingdom

Pfizer Investigational Site, Manchester M20 4BX, United Kingdom

Pfizer Investigational Site, Birmingham, Alabama 35233, United States

Pfizer Investigational Site, Birmingham, Alabama 35249, United States

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States

Pfizer Investigational Site, Badalona, Barcelona 08916, Spain

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, LaJolla, California 92093, United States

Pfizer Investigational Site, San Diego, California 92103-8976, United States

Pfizer Investigational Site, San Francisco, California 94143, United States

Pfizer Investigational Site, Nantes, Cedex 01 44093, France

Pfizer Investigational Site, Marseille, Cedex 09 13273, France

Pfizer Investigational Site, Gainesville, Florida 32610, United States

Pfizer Investigational Site, Miami, Florida 33136, United States

Pfizer Investigational Site, Atlanta, Georgia 30322, United States

Pfizer Investigational Site, Chicago, Illinois 60612, United States

Pfizer Investigational Site, Chicago, Illinois 60637, United States

Pfizer Investigational Site, Pune, Maharashtra 411004, India

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada

Pfizer Investigational Site, Winnipeg, Manitoba R3E 0V9, Canada

Pfizer Investigational Site, Baltimore, Maryland 21205, United States

Pfizer Investigational Site, Baltimore, Maryland 21231-2410, United States

Pfizer Investigational Site, Baltimore, Maryland 21231, United States

Pfizer Investigational Site, Baltimore, Maryland 21287, United States

Pfizer Investigational Site, Detroit, Michigan 48201, United States

Pfizer Investigational Site, Detroit, Michigan 48202, United States

Pfizer Investigational Site, Westmead, New South Wales 2145, Australia

Pfizer Investigational Site, Rochester, New York 14642, United States

Pfizer Investigational Site, Chapel Hill, North Carolina 27514, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27157, United States

Pfizer Investigational Site, Hamilton, Ontario L8N 3Z5, Canada

Pfizer Investigational Site, Hamilton, Ontario L8V 1C3, Canada

Pfizer Investigational Site, Portland, Oregon 97239, United States

Pfizer Investigational Site, Curitiba, PR 80060-900, Brazil

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States

Pfizer Investigational Site, Montreal, Quebec H1T 2M4, Canada

Pfizer Investigational Site, Herston, Queensland 4029, Australia

Pfizer Investigational Site, Rio de Janeiro, RJ 21941-913, Brazil

Pfizer Investigational Site, Porto Alegre, RS 90020-090, Brazil

Pfizer Investigational Site, Adelaide, South Australia 5000, Australia

Pfizer Investigational Site, Kuei-Shan Hsiang, Taoyuan County 333, Taiwan

Pfizer Investigational Site, Houston, Texas 77030, United States

Pfizer Investigational Site, Seattle, Washington 98109, United States

Pfizer Investigational Site, Seattle, Washington 98195, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2008
Last updated: April 3, 2012

Page last updated: August 23, 2015

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