Anidulafungin In Treatment Of Candidemia In Asian Subjects - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00537329

Purpose

The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

Condition	Intervention	Phase
Candidemia	Drug: Anidulafungin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients

Resource links provided by NLM:

Drug Information available for: Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the clinical efficacy of anidulafungin (in terms of global response to treatment at End of All Treatment, EOT) in the treatment of Asian subjects with candidemia. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess all cause mortality and mortality related to candidemia. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To characterize the relationship between Beta-D-glucan assay results and overall clinical and microbiological responses. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To allow characterization of the benefit of anidulafungin in terms of global response in pre-specified subgroups of interest at EOT. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To demonstrate the safety and tolerability of anidulafungin in the treatment of Asian patients with candidemia. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To evaluate efficacy of anidulafungin in terms of global response at the end of intravenous treatment (EOIT), 2, 6 weeks after EOT and at the end of 12 weeks from baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the clinical and microbiological responses at EOIT, EOT, 2 and 6 weeks after EOT and at the end of 12 weeks from baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	January 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.	Drug: Anidulafungin Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.

Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.
Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20

Exclusion Criteria:

Subjects who had, at any time, previously received anidulafungin

Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples
Life expectancy < 72 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537329

Locations

India, Gujarat
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
India, Karnataka
Pfizer Investigational Site
Bangalore, Karnataka, India, 560034
India, Maharashtra
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 022
India, Punjab
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 001
India, Uttar Pradesh
Pfizer Investigational Site
Noida, Uttar Pradesh, India, 201301
Philippines
Pfizer Investigational Site
Legaspi Village, Makati City, Philippines, 1200
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taichung, Taiwan, 404
Pfizer Investigational Site
Tainan, Taiwan, 704
Taiwan, Taipei
Pfizer Investigational Site
Pan-Chiao, Taipei, Taiwan, 220
Thailand, Bangkok
Pfizer Investigational Site
Pathumwan, Bangkok, Thailand, 10330
Thailand, Chiang Mai
Pfizer Investigational Site
Amphoe Mueang, Chiang Mai, Thailand, 50200
Thailand, Khon Kaen
Pfizer Investigational Site
Amphoe Mueang, Khon Kaen, Thailand, 40002

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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8851016, PF-03910960
Study First Received:	September 25, 2007
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00537329 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Echinocandins
Antifungal Agents
Anidulafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Echinocandins
Therapeutic Uses
Antifungal Agents

Antibiotics, Antifungal
Pharmacologic Actions
Anidulafungin

ClinicalTrials.gov processed this record on September 11, 2009