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Trial record 1 of 1 for:    NCT00805740
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An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

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ClinicalTrials.gov Identifier: NCT00805740
Recruitment Status : 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.)
First Posted : December 10, 2008
Results First Posted : August 1, 2013
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 26, 2008
First Posted Date  ICMJE December 10, 2008
Results First Submitted Date  ICMJE May 30, 2013
Results First Posted Date  ICMJE August 1, 2013
Last Update Posted Date August 1, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2008)
Global response at the end of treatment (EOT) in the modified intent-to-teat (MITT) group [ Time Frame: At end of treatment (Day 14 - 42) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2008)
  • Response based on clinical cure and microbiological success at EOT, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 42) and at the 2-week and 6-week follow-up visit ]
  • Time to negative blood culture (if subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 84) ]
  • Safety [ Time Frame: During and at end of study (Day 0 - 84) ]
  • Time to death [ Time Frame: During and at end of study (Day 0 - 84) ]
  • All cause mortality during study therapy and follow-up visits [ Time Frame: During and at end of study (Day 0 - 84) ]
  • Clinical response at Day 10 [ Time Frame: At Day 10 of treatment ]
  • Rates of relapse at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ]
  • Rates of new infection with an organism not identified at baseline and the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ]
  • Global response at the 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At the 2-week and 6-week follow-up visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
Official Title  ICMJE Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis
  • Fungemia
Intervention  ICMJE
  • Drug: Active anidulafungin
    Subjects in this arm will receive active anidulafungin and placebo caspofungin
  • Drug: Active Caspofungin
    Subjects in this arm will receive active caspofungin and placebo anidulafungin
Study Arms  ICMJE
  • Experimental: Anidulafungin arm
    Intervention: Drug: Active anidulafungin
  • Experimental: Caspofungin arm
    Intervention: Drug: Active Caspofungin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
41
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
45
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, 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 Belgium,   Bulgaria,   Canada,   Netherlands,   Portugal,   Romania,   Russian Federation,   Switzerland,   United States
Removed Location Countries Croatia
 
Administrative Information
NCT Number  ICMJE NCT00805740
Other Study ID Numbers  ICMJE A8851022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

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