Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00531479

Purpose

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	Intervention	Phase
Aspergillosis	Drug: voriconazole Drug: anidulafungin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Drug Information available for: Voriconazole Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis [ Time Frame: Day 1 to Day 42 (Week 6) ] [ Designated as safety issue: Yes ]
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:

Global Response at Week 6 [ Time Frame: Baseline, Day 42 (Week 6) ] [ Designated as safety issue: No ]
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.
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) ] [ Designated as safety issue: Yes ]
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.
All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA) [ Time Frame: Day 1 to Day 84 (Week 12) ] [ Designated as safety issue: Yes ]
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.
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) ] [ Designated as safety issue: Yes ]
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.
Time to Death: All-Cause Mortality [ Time Frame: Day 1 to Day 84 (Week 12) ] [ Designated as safety issue: Yes ]
Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
Time to Death Due to Invasive Aspergillosis (IA) [ Time Frame: Day 1 to Day 84 (Week 12) ] [ Designated as safety issue: Yes ]
Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.

Enrollment:	459
Study Start Date:	July 2008
Study Completion Date:	May 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531479

Show 107 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00531479 History of Changes
Other Study ID Numbers:	A8851009
Study First Received:	September 14, 2007
Results First Received:	April 3, 2012
Last Updated:	April 3, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012