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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00531479
Pfizer
Completed
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Aspergillosis
  • Drug: 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.

    Other Name: Vfend
  • 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.

    Other Name: Eraxis
  • 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.

    Other Name: Vfend
  • Active Comparator: Voriconazole
    Voriconazole monotherapy
    Intervention: Drug: voriconazole
  • Experimental: Voriconazole and Anidulafungin
    Combination therapy with voriconazole and anidulafungin
    Interventions:
    • Drug: anidulafungin
    • Drug: voriconazole


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
459
May 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Austria,   Saudi Arabia
 
NCT00531479
A8851009
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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