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

Study Overview
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Brief Summary
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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
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All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.

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

Conditions
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Candidiasis

Intervention / Treatment
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* Drug: anidulafungin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anidulafungin<br> | Drug: anidulafungin<br>* A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.<br>* Other names: ECALTA, ERAXIS;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, Ecalta, Eraxis, Candida, Candidemia, Systemic Candidiasis, Intensive Care Unit, Critical Care Unit