Clinical trial NCT01202253: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis
Keywords: Ecalta
Eraxis
Candida
Candidemia
Systemic Candidiasis
ICU
Intensive Care Unit
Critical Care Unit
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage of Participants With Favorable Outcome
timeFrame: Day 28 post-treatment
Secondary outcomes:
measure: Percentage of Participants With Unfavorable Outcome
timeFrame: Day 28 post-treatment
measure: Percentage of Participants Who Died Due to All Causes
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Death Attributable to Fungal Infection
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Death Unrelated to Fungal Infection
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Favorable Clinical Response
timeFrame: Day 28 post-treatment
measure: Percentage of Participants With Lack of Clinical Response
timeFrame: Day 28 post-treatment
measure: Percentage of Participants Requiring Change or Additional Antifungal Therapy
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Oral Antifungal Started to Complete Therapy
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Documented Eradication of Infecting Species
timeFrame: Baseline
measure: Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
timeFrame: Baseline
measure: Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
timeFrame: Day 28 post-treatment
measure: Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
timeFrame: Baseline
measure: Duration of Stay at Liver Intensive Therapy Unit (LITU)
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
timeFrame: Baseline
measure: Percentage of Participants With Concomitant Bacterial or Viral Infection
timeFrame: Baseline
measure: Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
timeFrame: Baseline
measure: Dose Changes for Immunosuppressant Drugs
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Number of Participants With Infection Sites as Per Microbiological Analysis
timeFrame: Baseline
measure: Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
timeFrame: Baseline
measure: Infecting Organisms by Species
timeFrame: Baseline up to Day 14 post-treatment
measure: Percentage of Participants With Prior Colonization With Candida by Species
timeFrame: Baseline
measure: Percentage of Participants With Prior Colonization With Candida by Colonization Index
timeFrame: Baseline
measure: Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
timeFrame: Baseline
measure: Number of Participants Who Received Water-based and Ethanol-based Formulation
timeFrame: Baseline
measure: Percentage of Participants Who Received Water-based and Ethanol-based Formulation
timeFrame: Baseline
measure: Percentage of Participants Who Received 200 mg Loading Dose
timeFrame: Day 1
measure: Percentage of Participants Who Received 100 mg Dose on Day 2
timeFrame: Day 2
measure: Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
timeFrame: Baseline up to Day 28 post-treatment
measure: Number of Participants With Other Dosing Patterns
timeFrame: Baseline up to Day 28 post-treatment
measure: Duration of Anidulafungin Therapy
timeFrame: Baseline
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 28 post-treatment
measure: Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 28 post-treatment
measure: Number of Participants With Different Types of Drug-related Serious Adverse Events
timeFrame: Baseline up to Day 28 post-treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: