Anidulafungin In Treatment Of Candidemia In Asian Subjects

NCT00537329

Last updated date
Study Location
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 054, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior exposure to systemic antifungals for more than 48 hours.


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Anidulafungin In Treatment Of Candidemia In Asian Subjects
Official Title  ICMJE A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Candidemia
Intervention  ICMJE 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.
Study Arms  ICMJE Open
This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.
Intervention: Drug: Anidulafungin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2010)
43
Original Enrollment  ICMJE
 (submitted: September 27, 2007)
100
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • Prior exposure to systemic antifungals for more than 48 hours.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Philippines,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537329
Other Study ID Numbers  ICMJE A8851016
PF-03910960
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP