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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00531479
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aspergillosis Drug: voriconazole Drug: anidulafungin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Voriconazole
Voriconazole monotherapy
 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
Experimental: Voriconazole and Anidulafungin
Combination therapy with voriconazole and anidulafungin
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531479


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00531479    
Other Study ID Numbers: A8851009
First Posted: September 18, 2007    Key Record Dates
Results First Posted: April 30, 2012
Last Update Posted: April 30, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Voriconazole
Anidulafungin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors