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Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

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NCT01202253

Last updated on November 12, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
London, , SE5 9RS United Kingdom
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th
September 2010.

Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit
during this period

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

- Patients who participated in any interventional clinical trial during this episode of
sepsis.

Patients who received anidulafungin for infection prophylaxis

NCT01202253
Pfizer
Completed
Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

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[email protected]

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Descriptive Information
Brief TitleEarly Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
Official TitleA Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London
Brief SummaryThe purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.
Detailed DescriptionAll subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationSubjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
ConditionCandidiasis
InterventionDrug: anidulafungin
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Other Name: ECALTA, ERAXIS
Study Groups/CohortsAnidulafungin
Intervention: Drug: anidulafungin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 13, 2010)		50
Original Estimated EnrollmentSame as current
Actual Study Completion DateMay 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September 2010.

Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period

Exclusion Criteria:

  • Patients who participated in any interventional clinical trial during this episode of sepsis.

Patients who received anidulafungin for infection prophylaxis

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01202253
Other Study ID NumbersA8851028
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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