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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

NCT ID: NCT00531479

Last Updated: 2012-04-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-05-31

Brief Summary

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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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Conditions

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Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Voriconazole

Voriconazole monotherapy

Group Type ACTIVE_COMPARATOR

voriconazole

Intervention Type 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.

Voriconazole and Anidulafungin

Combination therapy with voriconazole and anidulafungin

Group Type EXPERIMENTAL

anidulafungin

Intervention Type 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.

voriconazole

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Vfend Eraxis Vfend

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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La Jolla, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Westmead, New South Wales, Australia

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Herston, Queensland, Australia

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Adelaide, South Australia, Australia

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Bruges, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Yvoir, , Belgium

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Prague, , Czechia

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Nantes, Cedex 01, France

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Marseille, Cedex 09, France

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Brest, , France

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Créteil, , France

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Grenoble, , France

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Paris, , France

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Rouen, , France

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Strasbourg, , France

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Berlin, , Germany

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Bremen, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Frankfurt (Oder), , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Homburg/Saar, , Germany

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Mainz, , Germany

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München, , Germany

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Würzburg, , Germany

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Thessaloniki, , Greece

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Pune, Maharashtra, India

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Cuneo, , Italy

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Genova, , Italy

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Milan, , Italy

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Perugia, , Italy

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Pescara, , Italy

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Roma, , Italy

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RC Leiden, , Netherlands

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Lima, Lima Province, Peru

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Gdansk, , Poland

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Warsaw, , Poland

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Lisbon, , Portugal

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Moscow, , Russia

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, Barcelona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Salamanca, Salamanca, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Kuei-Shan Hsiang, Taoyuan County, Taiwan

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Bangkok, Thailand, Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Australia Belgium Brazil Canada Czechia France Germany Greece India Italy Netherlands Peru Poland Portugal Russia Singapore South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25599346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24914120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24913161 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851009&StudyName=Anidulafungin%20Plus%20Voriconazole%20versus%20Voriconazole%20For%20The%20Treatment%20Of%20Invasive%20Aspergillosis

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

Other Identifiers

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A8851009

Identifier Type: -

Identifier Source: org_study_id

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