An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

NCT00806351

Last updated date
Study Location
Pfizer Investigational Site
Sarajevo, , 71000, Bosnia and Herzegovina
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fungemia, Neutropenia, Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Dysfunctional immune system (reduced neutrophils).

- Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.

- Male of female ≥16 years of age.

- Expected hospitalization for at least ten (10) days.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Fungemia, Neutropenia, CandidiasisAn Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
NCT00806351
  1. Sarajevo,
  2. GRENOBLE Cedex 09,
  3. Strasbourg Cedex,
  4. Bologna,
  5. Roma,
  6. Gdansk,
  7. Warszawa,
  8. Wroclaw,
  9. Moscow,
  10. Kosice,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Official Title  ICMJE Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection
Brief Summary The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. 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
  • Fungemia
  • Neutropenia
  • Candidiasis
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
    Subjects were randomized 2:1 (anidulafungin:caspofunin).
    Intervention: Drug: Active Anidulafungin
  • Experimental: Caspofungin Arm
    Subjects were randomized 2:1 (anidulafungin:caspofunin).
    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)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
45
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Dysfunctional immune system (reduced neutrophils).
  • Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
  • Male of female ?16 years of age.
  • Expected hospitalization for at least ten (10) 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 Bosnia and Herzegovina,   France,   Italy,   Poland,   Russian Federation,   Slovakia
Removed Location Countries Bulgaria,   Canada,   Croatia,   Netherlands,   Romania,   Switzerland,   United States
 
Administrative Information
NCT Number  ICMJE NCT00806351
Other Study ID Numbers  ICMJE A8851021
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2012

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