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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis

Intervention: anidulafungin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Percentage of Participants With Favorable Outcome

Secondary outcome:

Percentage of Participants With Unfavorable Outcome

Percentage of Participants Who Died Due to All Causes

Percentage of Participants With Death Attributable to Fungal Infection

Percentage of Participants With Death Unrelated to Fungal Infection

Percentage of Participants With Favorable Clinical Response

Percentage of Participants With Lack of Clinical Response

Percentage of Participants Requiring Change or Additional Antifungal Therapy

Percentage of Participants With Oral Antifungal Started to Complete Therapy

Percentage of Participants With Documented Eradication of Infecting Species

Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results

Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results

Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy

Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy

Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy

Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy

Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)

Duration of Stay at Liver Intensive Therapy Unit (LITU)

Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3

Percentage of Participants With Concomitant Bacterial or Viral Infection

Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start

Dose Changes for Immunosuppressant Drugs

Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy

Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy

Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy

Number of Participants With Infection Sites as Per Microbiological Analysis

Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan

Infecting Organisms by Species

Percentage of Participants With Prior Colonization With Candida by Species

Percentage of Participants With Prior Colonization With Candida by Colonization Index

Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index

Number of Participants Who Received Water-based and Ethanol-based Formulation

Percentage of Participants Who Received Water-based and Ethanol-based Formulation

Percentage of Participants Who Received 200 mg Loading Dose

Percentage of Participants Who Received 100 mg Dose on Day 2

Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses

Number of Participants With Other Dosing Patterns

Duration of Anidulafungin Therapy

Number of Serious Adverse Events (SAEs)

Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)

Number of Participants With Different Types of Drug-related Serious Adverse Events

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, London SE5 9RS, United Kingdom
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2011
Last updated: March 25, 2014

Page last updated: August 20, 2015

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