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Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wien, , A-1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and
belonging to one or more of the following specific populations:

- Post-abdominal surgery.

- Elderly > 65 years old.

- Renal insufficiency / failure / hemodialysis.

- Solid tumor.

- Solid-organ (liver, kidney, lung, heart) transplant recipients.

- Hepatic insufficiency.

- Neutropenic including hematology oncology patients.

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

Patients with poor venous access that would preclude IV drug delivery or multiple blood
draws.

NCT00689338
Pfizer
Completed
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

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Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations
To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Invasive Candidiasis
  • Drug: Anidulafungin
    Anidulafungin Intravenous Administration
  • Drug: Fluconazole
    Oral Administration of Fluconazole
  • Drug: Voriconazole
    Oral Administration of Voriconazole
Experimental: Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
  • Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
216
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

  • Post-abdominal surgery.
  • Elderly > 65 years old.
  • Renal insufficiency / failure / hemodialysis.
  • Solid tumor.
  • Solid-organ (liver, kidney, lung, heart) transplant recipients.
  • Hepatic insufficiency.
  • Neutropenic including hematology oncology patients.

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Turkey,   Ukraine,   United Kingdom
 
 
NCT00689338
A8851019
No
Not Provided
Not Provided
Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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