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

A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London

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.

Study Overview

• Status: Completed
• Conditions: Candidiasis
• Intervention / Treatment: Drug: anidulafungin

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
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anidulafungin	Drug: anidulafungin; A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.; Other Names: ECALTA, ERAXIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Favorable Outcome	Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.	Day 28 post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Unfavorable Outcome	Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.	Day 28 post-treatment
Percentage of Participants Who Died Due to All Causes	Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.	Baseline up to Day 28 post-treatment
Percentage of Participants With Death Attributable to Fungal Infection		Baseline up to Day 28 post-treatment
Percentage of Participants With Death Unrelated to Fungal Infection		Baseline up to Day 28 post-treatment
Percentage of Participants With Favorable Clinical Response	Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.	Day 28 post-treatment
Percentage of Participants With Lack of Clinical Response	Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.	Day 28 post-treatment
Percentage of Participants Requiring Change or Additional Antifungal Therapy	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).	Baseline up to Day 28 post-treatment
Percentage of Participants With Oral Antifungal Started to Complete Therapy		Baseline up to Day 28 post-treatment
Percentage of Participants With Documented Eradication of Infecting Species	Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.	Baseline
Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results	An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.	Baseline up to Day 28 post-treatment
Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results	A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.	Baseline up to Day 28 post-treatment
Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy	Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).	Baseline
Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy	Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.	Day 28 post-treatment
Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy	Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.	Baseline up to Day 28 post-treatment
Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy		Baseline up to Day 28 post-treatment
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)		Baseline
Duration of Stay at Liver Intensive Therapy Unit (LITU)		Baseline up to Day 28 post-treatment
Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).	Baseline
Percentage of Participants With Concomitant Bacterial or Viral Infection	Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).	Baseline
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).	Baseline
Dose Changes for Immunosuppressant Drugs		Baseline up to Day 28 post-treatment
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy		Baseline
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	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).	Baseline
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	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).	Baseline
Number of Participants With Infection Sites as Per Microbiological Analysis	Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.	Baseline
Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan		Baseline
Infecting Organisms by Species		Baseline up to Day 14 post-treatment
Percentage of Participants With Prior Colonization With Candida by Species	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).	Baseline
Percentage of Participants With Prior Colonization With Candida by Colonization Index		Baseline
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index		Baseline
Number of Participants Who Received Water-based and Ethanol-based Formulation		Baseline
Percentage of Participants Who Received Water-based and Ethanol-based Formulation		Baseline
Percentage of Participants Who Received 200 mg Loading Dose		Day 1
Percentage of Participants Who Received 100 mg Dose on Day 2		Day 2
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses		Baseline up to Day 28 post-treatment
Number of Participants With Other Dosing Patterns	The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.	Baseline up to Day 28 post-treatment
Duration of Anidulafungin Therapy		Baseline
Number of Serious Adverse Events (SAEs)	Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline up to Day 28 post-treatment
Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)		Baseline up to Day 28 post-treatment
Number of Participants With Different Types of Drug-related Serious Adverse Events		Baseline up to Day 28 post-treatment

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: ICU; Intensive Care Unit; Candida; Candidemia; Critical Care Unit; Systemic Candidiasis; Ecalta; Eraxis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Bacterial Infections and Mycoses; Mycoses; Liver Diseases; Candidiasis; Anti-Infective Agents; Antifungal Agents; Anidulafungin
• Other Study ID Numbers: A8851028