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NCT Number: NCT00531479

Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of 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.

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Key information

Conditions

Aspergillosis Bacterial Infections and Mycoses Infections Mycoses

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Vfend

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.

Other names: Eraxis

Primary outcomes

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

    Time frame: Day 1 to Day 42 (Week 6)

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

Secondary outcomes

  1. Global Response at Week 6

    Time frame: Baseline, Day 42 (Week 6)

    Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.

  2. 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)

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

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

    Time frame: Day 1 to Day 84 (Week 12)

    Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

  4. 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)

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

  5. Time to Death: All-Cause Mortality

    Time frame: Day 1 to Day 84 (Week 12)

    Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.

  6. Time to Death Due to Invasive Aspergillosis (IA)

    Time frame: Day 1 to Day 84 (Week 12)

    Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 18, 2007
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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