An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00806351

Purpose

The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Condition	Intervention	Phase
Fungemia Neutropenia Candidiasis	Drug: Active Anidulafungin Drug: Active Caspofungin	Phase III

MedlinePlus related topics: Fungal Infections Molds Yeast Infections

Drug Information available for: Anidulafungin Caspofungin Caspofungin Acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection

Further study details as provided by Pfizer:

Primary Outcome Measures:

Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy in the modified intent to treat (MITT) group [ Time Frame: At end of intravenous treatment (Day 10 - 42) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response (based on clinical cure and microbiologic success) at the end of intravenous treatment, end of treatment, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 56) and at the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
Clinical response at Day 10 of treatment [ Time Frame: At Day 10 of treatment ] [ Designated as safety issue: No ]
Rates of relapse at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
Rates of new infection with an organism not identified at baseline at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
Global response at end of treatment, and at the 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
Time to negative blood culture (if the subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]
Safety [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
Time to death [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
All cause mortality during the study therapy and at follow visits [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Anidulafungin Arm: Experimental	Drug: Active Anidulafungin Subjects in this arm will receive active anidulafungin and placebo caspofungin
Caspofungin Arm: Experimental	Drug: Active Caspofungin Subjects in this arm will receive active caspofungin and placebo anidulafungin

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Dysfunctional immune system (reduced neutrophils); Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection; Male of female ≥16 years of age; Expected hospitalization for at least ten (10) days.

Exclusion Criteria:

Pregnancy or breast feeding or planning to become pregnant during the study; Recent treatment with one of the study drugs over the last 30 days; Allergy to either study drug or to this class of drugs; Significant liver dysfunction; Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806351

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

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:	A8851021
Study First Received:	November 26, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00806351
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Candiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Echinocandins
Candidiasis
Clotrimazole
Hematologic Diseases
Miconazole
Caspofungin
Tioconazole
Agranulocytosis
Leukocyte Disorders

Granulocytopenia
Anidulafungin
Inflammation
Mycoses
Neutropenia
Sepsis
Fungemia
Leukopenia
Torulopsis

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Therapeutic Uses
Antifungal Agents

Antibiotics, Antifungal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009