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

Sponsors and Collaborators:	Pfizer Mycoses Study Group
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00531479

Purpose

The combination of anidulafungin plus voriconazole may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to compare the effectiveness and safety of anidulafungin in combination with voriconazole

Condition	Intervention	Phase
Aspergillosis	Drug: voriconazole Drug: anidulafungin	Phase III

Drug Information available for: Anidulafungin Voriconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is all cause mortality, measured 6 weeks after IA initiation of study drug in subjects with proven or probable IA. [ Time Frame: 6 weeks after IA initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of global response at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
All cause mortality at 6 weeks in subjects with possible, probable, or proven IA [ Time Frame: All cause mortality at 6 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of voriconazole monotherapy compared to that of voriconazole in combination with anidulafungin [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
All cause mortality at 12 weeks in subjects with probable or proven IA [ Time Frame: All cause mortality at 12 weeks ] [ Designated as safety issue: No ]
Mortality due to IA at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
Time to death (all cause mortality) [ Time Frame: Time to death (all cause mortality) ] [ Designated as safety issue: No ]

Estimated Enrollment:	335
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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.
2: Experimental	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. Drug: voriconazole As above

Arms

Assigned Interventions

1: Active Comparator

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.

2: Experimental

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.

Drug: voriconazole

As above

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 receipt of hematopoeitic stem cell transplantation or 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 <=30

Contacts and Locations

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 122 Study Locations

Sponsors and Collaborators

Pfizer

Mycoses Study Group

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8851009
Study First Received:	September 14, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00531479
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mycoses
Echinocandins
Clotrimazole
Miconazole

Voriconazole
Tioconazole
Aspergillosis
Anidulafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009