Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00689338

Purpose

To evaluate the efficacy and safety of anidulfungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Condition	Intervention	Phase
Candida Candidiasis	Drug: Anidulafungin Drug: Fluconazole Drug: Voriconazole	Phase III

MedlinePlus related topics: Critical Care Yeast Infections

Drug Information available for: Anidulafungin Fluconazole Voriconazole

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy endpoint will be the global treatment response at the End of Treatment. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global response at the End of Intra Venous Treatment, at 2 weeks after End of Treatment and at 6 weeks after End of Treatment. [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
Time to first negative blood/tissue culture (defined as first negative culture which is not followed by positive culture within the next 3 days). [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
Day 90 survival [ Time Frame: up to 100 days ] [ Designated as safety issue: No ]
Time to ICU discharge. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
Incidence of adverse events and discontinuation from study treatment. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	286
Study Start Date:	July 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group: Experimental Option to treat with oral azole therapy following treatment with anidulfungin	Drug: Anidulafungin Anidulafungin Intravenous Administration Drug: Fluconazole Oral Administration of Fluconazole Drug: Voriconazole Oral Administration of Voriconazole

Eligibility

Criteria

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689338

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

Responsible Party:	Pfizer, Inc. ( Clinical Trials Disclosure Group )
Study ID Numbers:	A8851019
Study First Received:	May 29, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00689338
Health Authority:	United Kingdom: Department of Health

Keywords provided by Pfizer:

Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit, Anidulafungin, Ecalta, Eraxis, Fluconazole, Voriconazole

Study placed in the following topic categories:

Fluconazole
Mycoses
Echinocandins
Candidiasis
Clotrimazole

Miconazole
Voriconazole
Tioconazole
Torulopsis
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