Anidulafungin In Treatment Of Candidemia In Asian Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00537329
First received: September 25, 2007
Last updated: March 4, 2010
Last verified: March 2010
  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 3

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: A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Global Response of Success at End of Treatment [ Time Frame: End of treatment (EOT) = Day 5 up to Day 42 ] [ Designated as safety issue: No ]
    Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.


Secondary Outcome Measures:
  • Number of Subjects With Global Response of Success at Endpoints [ Time Frame: End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) ] [ Designated as safety issue: No ]
    Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.

  • Number of Subjects With Clinical Response of Success at Endpoints [ Time Frame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline ] [ Designated as safety issue: No ]
    Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.

  • Number of Subjects With Microbiological Response of Success at Endpoints [ Time Frame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline ] [ Designated as safety issue: No ]
    Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.

  • Time to Death From Any Cause [ Time Frame: Baseline through end of 12 weeks after baseline ] [ Designated as safety issue: Yes ]
    Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

  • Time to Death Due to Candidemia [ Time Frame: Baseline through end of 12 weeks after baseline ] [ Designated as safety issue: Yes ]
    Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

  • Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.

  • Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

  • Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).

  • Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

  • Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups [ Time Frame: EOT (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.


Enrollment: 43
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
Pfizer Investigational Site
Bangalore, Karnataka, India, 560034
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 022
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 001
Pfizer Investigational Site
Noida, Uttar Pradesh, India, 201301
Philippines
Pfizer Investigational Site
Legaspi Village, Makati City, Philippines, 1200
Taiwan
Pfizer Investigational Site
Pan-Chiao, Taipei, Taiwan, 220
Pfizer Investigational Site
Taichung, Taiwan, 404
Pfizer Investigational Site
Tainan, Taiwan, 704
Pfizer Investigational Site
Taipei, Taiwan, 100
Thailand
Pfizer Investigational Site
Pathumwan, Bangkok, Thailand, 10330
Pfizer Investigational Site
Amphoe Mueang, Chiang Mai, Thailand, 50200
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00537329     History of Changes
Other Study ID Numbers: A8851016, PF-03910960
Study First Received: September 25, 2007
Results First Received: January 19, 2010
Last Updated: March 4, 2010
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014