NCT00537329

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 17, 2010

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

September 25, 2007

Results QC Date

January 19, 2010

Last Update Submit

March 4, 2010

Conditions

Candidemia

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Global Response of Success at End of Treatment

    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.

    End of treatment (EOT) = Day 5 up to Day 42

Secondary Outcomes (10)

  • Number of Subjects With Global Response of Success at Endpoints

    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)

  • Number of Subjects With Clinical Response of Success at Endpoints

    EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline

  • Number of Subjects With Microbiological Response of Success at Endpoints

    EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline

  • Time to Death From Any Cause

    Baseline through end of 12 weeks after baseline

  • Time to Death Due to Candidemia

    Baseline through end of 12 weeks after baseline

  • +5 more secondary outcomes

Study Arms (1)

Open

OTHER

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

Interventions

AnidulafunginDRUG

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.

Open

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 054, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560034, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 022, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 001, India

Location

Pfizer Investigational Site

Noida, Uttar Pradesh, 201301, India

Location

Pfizer Investigational Site

Legaspi Village, Makati City, 1200, Philippines

Location

Pfizer Investigational Site

Banqiao District, Taipei, 220, Taiwan

Location

Pfizer Investigational Site

Taichung, 404, Taiwan

Location

Pfizer Investigational Site

Tainan, 704, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Pathumwan, Bangkok, 10330, Thailand

Location

Pfizer Investigational Site

Amphoe Mueang, Changwat Khon Kaen, 40002, Thailand

Location

Pfizer Investigational Site

Amphoe Mueang, Chiang Mai, 50200, Thailand

Location

Related Publications (5)

  • De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.

    PMID: 33891293DERIVED

  • Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.

    PMID: 31280481DERIVED

  • Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

    PMID: 28597967DERIVED

  • Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.

    PMID: 28459966DERIVED

  • Mootsikapun P, Hsueh PR, Talwar D, Co VM, Rajadhyaksha V, Ong ML. Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial. BMC Infect Dis. 2013 May 15;13:219. doi: 10.1186/1471-2334-13-219.

    PMID: 23676114DERIVED

Related Links

MeSH Terms

Conditions

Candidemia

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

October 1, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 9, 2010

Results First Posted

February 17, 2010

Record last verified: 2010-03

Locations

TH(3)IN(5)PH(1)TW(4)