Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
NCT01202253
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- 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
- Patients who participated in any interventional clinical trial during this episode of
sepsis.
Patients who received anidulafungin for infection prophylaxis
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Descriptive Information | ||||
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Brief Title | Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom | |||
Official Title | A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London | |||
Brief Summary | The 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 Description | All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin. | |||
Condition | Candidiasis | |||
Intervention | Drug: 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/Cohorts | Anidulafungin
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 Status | Completed | |||
Actual Enrollment | 50 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period Exclusion Criteria:
Patients who received anidulafungin for infection prophylaxis | |||
Sex/Gender |
| |||
Ages | 18 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01202253 | |||
Other Study ID Numbers | A8851028 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2014 |