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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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NCT00805740

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Newark, Delaware, 19713 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Fungemia
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

- 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
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.

NCT00805740
Pfizer
Terminated
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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An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Candidiasis
  • Fungemia
  • 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
  • Experimental: Anidulafungin arm
    Intervention: Drug: Active anidulafungin
  • Experimental: Caspofungin arm
    Intervention: Drug: Active Caspofungin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   Canada,   Netherlands,   Portugal,   Romania,   Russian Federation,   Switzerland,   United States
Croatia
 
NCT00805740
A8851022
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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