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

This study has been terminated.
(The study was terminated prematurely on May 18, 2012 due to slow enrollment. The study was not terminated due to any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00805740
First received: November 26, 2008
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Candidiasis
Fungemia
Drug: Active anidulafungin
Drug: Active Caspofungin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Clinical Response [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Relapse [ Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With New Infection [ Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) ] [ Designated as safety issue: No ]
    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.

  • Time to Negative Blood Culture [ Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • Time to Death [ Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT) ] [ Designated as safety issue: Yes ]
    Time to death (days) was assessed as date of death minus first treatment date plus 1.


Enrollment: 41
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00805740

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00805740     History of Changes
Other Study ID Numbers: A8851022
Study First Received: November 26, 2008
Results First Received: May 30, 2013
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection

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

ClinicalTrials.gov processed this record on August 28, 2014