Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

NCT00531479 | Completed Phase 3 Results DMC

• 1 other identifier: A8851009
• Study Type: interventional
• Target: 459
• Locations: 24 countries
• Sites: 107

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.

Conditions

Aspergillosis

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis

  Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

  Day 1 to Day 42 (Week 6)

Secondary Outcomes (6)

• Global Response at Week 6

  Baseline, Day 42 (Week 6)

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

  Day 1 to Day 42 (Week 6)

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

  Day 1 to Day 84 (Week 12)

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

  Day 1 to Day 42 (Week 6)

• Time to Death: All-Cause Mortality

  Day 1 to Day 84 (Week 12)

Study Arms (2)

Voriconazole

ACTIVE COMPARATOR

Voriconazole monotherapy

Drug: voriconazole

Voriconazole and Anidulafungin

EXPERIMENTAL

Combination therapy with voriconazole and anidulafungin

Drug: anidulafungin; Drug: voriconazole

Interventions

voriconazole DRUG

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.

Also known as: Vfend

Voriconazole

anidulafungin DRUG

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.

Also known as: Eraxis

Voriconazole and Anidulafungin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
• Diagnosis of possible, probable, or proven invasive aspergillosis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (107)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35249, United States

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Little Rock, Arkansas, 72205, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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San Diego, California, 92103-8976, United States

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San Francisco, California, 94143, United States

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Gainesville, Florida, 32610, United States

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Miami, Florida, 33136, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21205, United States

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Baltimore, Maryland, 21231-2410, United States

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Baltimore, Maryland, 21231, United States

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Baltimore, Maryland, 21287, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Rochester, New York, 14642, United States

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Chapel Hill, North Carolina, 27514, United States

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Winston-Salem, North Carolina, 27157, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19104, United States

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Houston, Texas, 77030, United States

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Seattle, Washington, 98109, United States

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Seattle, Washington, 98195, United States

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Westmead, New South Wales, 2145, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Bruges, 8000, Belgium

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Brussels, 1000, Belgium

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Leuven, 3000, Belgium

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Yvoir, B-5530, Belgium

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Curitiba, Paraná, 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Winnipeg, Manitoba, R3A 1R9, Canada

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Winnipeg, Manitoba, R3E 0V9, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Hamilton, Ontario, L8V 1C3, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1R 2J6, Canada

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Prague, 128 20, Czechia

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Nantes, Cedex 01, 44093, France

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Marseille, Cedex 09, 13273, France

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Brest, 29609, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Paris, 75475, France

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Rouen, 76038, France

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Strasbourg, 67098, France

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Berlin, 10117, Germany

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Berlin, 12200, Germany

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Bremen, 28177, Germany

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Cologne, 50937, Germany

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Dresden, 01307, Germany

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Frankfurt (Oder), 15236, Germany

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Hamburg, 20246, Germany

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Heidelberg, 69120, Germany

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Homburg/Saar, 66421, Germany

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Mainz, 55101, Germany

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München, 81737, Germany

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Würzburg, 97080, Germany

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Thessaloniki, 57010, Greece

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Pune, Maharashtra, 411004, India

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Cuneo, 12100, Italy

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Genova, 16132, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Perugia, 06134, Italy

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Pescara, 65100, Italy

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Roma, 00168, Italy

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RC Leiden, NL-2300, Netherlands

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Lima, Lima Province, Lima 34, Peru

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Gdansk, 80-952, Poland

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Warsaw, 02-097, Poland

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Lisbon, 1169-050, Portugal

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Lisbon, 1649-035, Portugal

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Moscow, 105229, Russia

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Moscow, 115478, Russia

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Moscow, 125167, Russia

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Saint Petersburg, 197089, Russia

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 169608, Singapore

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Seoul, 150-713, South Korea

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Badalona, Barcelona, 08916, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28050, Spain

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Salamanca, Salamanca, 37007, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46026, Spain

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Geneva, CH-1211, Switzerland

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Lausanne, 1011, Switzerland

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Kuei-Shan Hsiang, Taoyuan County, 333, Taiwan

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Kaohsiung City, 807, Taiwan

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Taipei, 112, Taiwan

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Bangkok, Thailand, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Adana, 01330, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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London, SE5 9RS, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Related Publications (3)

• Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508.

  PMID: 25599346 DERIVED

• Liu P, Mould DR. Population pharmacokinetic-pharmacodynamic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4727-36. doi: 10.1128/AAC.02809-13. Epub 2014 Jun 9.

  PMID: 24914120 DERIVED

• Liu P, Mould DR. Population pharmacokinetic analysis of voriconazole and anidulafungin in adult patients with invasive aspergillosis. Antimicrob Agents Chemother. 2014 Aug;58(8):4718-26. doi: 10.1128/AAC.02808-13. Epub 2014 Jun 9.

  PMID: 24913161 DERIVED

Related Links

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

MeSH Terms

Conditions

Aspergillosis

Interventions

Voriconazole; Anidulafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 18, 2007
• Study Start: July 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 30, 2012
• Results First Posted: April 30, 2012

Record last verified: 2012-04

Locations

US (26); TU (2); NL (1); IT (7); PL (2); DE (12); KR (5); ES (6); TH (3); CZ (1); TW (3); BR (3); GR (1); RU (4); AU (3); PE (1); SG (2); IN (1); PT (2); BE (4); CA (6); FR (8); CH (2); GB (2)