Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis - Full Text View

Purpose

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Condition	Intervention	Phase
Candidiasis Candida	Drug: anidulafungin	Phase IV

MedlinePlus related topics:

Molds Yeast Infections

ChemIDplus related topics:

Anidulafungin Fluconazole Voriconazole BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy endpoint will be a global response consisting of a combination of clinical and microbiological responses. The clinical response will be assessed by the investigator at the End of Treatment (EOT) visit. [ Time Frame: 6 weeks after end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global response rate at the End of IV Treatment (EOIV) as well as the Week 2 and Week 6 week follow up visits. Time to negative blood/tissue culture. Evaluation of Medical Resource Utilization with the use of data collection for predefined data points. [ Time Frame: Up to 6 weeks after end of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

anidulafungin: Experimental

Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.

Drug: anidulafungin

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Eligibility

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

Criteria

Inclusion Criteria:

Male or female subjects > or equal to 18 years of age.
Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion Criteria:

Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
Subjects with infected prosthetic devices which cannot be removed within 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496197

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 45 Study Locations

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:	A8851011
First Received:	July 3, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00496197
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

candidemia, invasive candidiasis, fungal bloodstream infection

Study placed in the following topic categories:

Fluconazole

Mycoses

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 October 06, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00496197