An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

May 30, 2013 updated by: Pfizer

Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection

The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1000
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1606
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Pfizer Investigational Site
      • Amsterdam, Netherlands, 1081 HZ
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3040-853
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1150-199
        • Pfizer Investigational Site
  • Romania
      • Bucuresti, Romania, 014461
        • Pfizer Investigational Site
  • Russian Federation
      • P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, Russian Federation, 143423
        • Pfizer Investigational Site
  • Switzerland
      • Geneve 14, Switzerland, CH-1211
        • Pfizer Investigational Site
  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Pfizer Investigational Site
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
      • Wilmington, Delaware, United States, 19801
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
  • Male or female ≥ 16 years of age.
  • Expected hospitalization for at least fourteen (14) days.

Exclusion Criteria:

  • Pregnancy or breast feeding or planning to become pregnant during the study.
  • Recent treatment with one of the study drugs over the last 30 days.
  • Allergy to either study drug or to this class of drugs.
  • Significant liver dysfunction.
  • Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anidulafungin arm
Drug: Active anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
EXPERIMENTAL: Caspofungin arm
Drug: Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
Time Frame: End of Treatment (Day 14 to Day 42)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
End of Treatment (Day 14 to Day 42)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit
Time Frame: 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Response Based on Clinical Cure and Microbiological Success
Time Frame: EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.
EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Clinical Response
Time Frame: Day 10
A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.
Day 10
Percentage of Participants With Relapse
Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.
2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With New Infection
Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.
2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Time to Negative Blood Culture
Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT)
Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.
Baseline up to 6-week follow-up (6 weeks after EOT)
Percentage of Participants With All-cause Mortality
Time Frame: Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)
All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.
Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)
Time to Death
Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT)
Time to death (days) was assessed as date of death minus first treatment date plus 1.
Baseline up to 6-week follow-up (6 weeks after EOT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (ESTIMATE)

December 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8851022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Candidiasis

Clinical Trials on Active anidulafungin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe