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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01202253
First received: September 13, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Candidiasis
Drug: anidulafungin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Favorable Outcome [ Time Frame: Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Unfavorable Outcome [ Time Frame: Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Died Due to All Causes [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]
    Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.

  • Percentage of Participants With Death Attributable to Fungal Infection [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Death Unrelated to Fungal Infection [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Favorable Clinical Response [ Time Frame: Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Lack of Clinical Response [ Time Frame: Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Requiring Change or Additional Antifungal Therapy [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Oral Antifungal Started to Complete Therapy [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Documented Eradication of Infecting Species [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.

  • Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
    An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

  • Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
    A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

  • Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy [ Time Frame: Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Duration of Stay at Liver Intensive Therapy Unit (LITU) [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Concomitant Bacterial or Viral Infection [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Dose Changes for Immunosuppressant Drugs [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Infection Sites as Per Microbiological Analysis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.

  • Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Infecting Organisms by Species [ Time Frame: Baseline up to Day 14 post-treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants With Prior Colonization With Candida by Species [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Prior Colonization With Candida by Colonization Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of Participants Who Received Water-based and Ethanol-based Formulation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received Water-based and Ethanol-based Formulation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received 200 mg Loading Dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received 100 mg Dose on Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
  • Number of Participants With Other Dosing Patterns [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: No ]
    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.

  • Duration of Anidulafungin Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]
  • Number of Participants With Different Types of Drug-related Serious Adverse Events [ Time Frame: Baseline up to Day 28 post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anidulafungin Drug: anidulafungin
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Other Name: ECALTA, ERAXIS

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202253

Locations
United Kingdom
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01202253     History of Changes
Other Study ID Numbers: A8851028
Study First Received: September 13, 2010
Results First Received: April 6, 2012
Last Updated: March 25, 2014
Health Authority: United Kingdom: Department of Health

Keywords provided by Pfizer:
Ecalta
Eraxis
Candida
Candidemia
Systemic Candidiasis
ICU
Intensive Care Unit
Critical Care Unit

Additional relevant MeSH terms:
Candidiasis
Liver Diseases
Mycoses
Digestive System Diseases
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014