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

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

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Yeast Infections

Drug Information available for: Fluconazole Voriconazole Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Participants With Global Treatment Response Success at End of Treatment [ Time Frame: End of Treatment (Day 14 to Day 56) ] [ Designated as safety issue: No ]
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

Secondary Outcome Measures:

Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) [ Time Frame: EOIVT (Day 10 up to Day 42) ] [ Designated as safety issue: No ]
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment [ Time Frame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) ] [ Designated as safety issue: No ]
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Percentage of Participants With Global Response Success 6 Weeks After End of Treatment [ Time Frame: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) ] [ Designated as safety issue: No ]
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
Time to First Negative Blood Culture [ Time Frame: Day 1 up to Day 42 ] [ Designated as safety issue: No ]
Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.
Day 90 Survival [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Percentage of participants known or assumed to be alive on Day 90.
Time to Successful Intensive Care Unit (ICU) Discharge [ Time Frame: Day 1 up to Day 56 ] [ Designated as safety issue: No ]
Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.

Enrollment:	216
Study Start Date:	July 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Post-abdominal surgery.
Elderly > 65 years old.
Renal insufficiency / failure / hemodialysis.
Solid tumor.
Solid-organ (liver, kidney, lung, heart) transplant recipients.
Hepatic insufficiency.
Neutropenic including hematology oncology patients.

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

Show 61 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:	Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00689338 History of Changes
Other Study ID Numbers:	A8851019
Study First Received:	May 29, 2008
Results First Received:	April 21, 2011
Last Updated:	May 25, 2011
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

Additional relevant MeSH terms:

Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole

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 February 09, 2012