Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
25 maart 2014 bijgewerkt door: Pfizer
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.
Studie Overzicht
Gedetailleerde beschrijving
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Studietype
Observationeel
Inschrijving (Werkelijk)
50
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
London, Verenigd Koninkrijk, SE5 9RS
- Pfizer Investigational Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Anidulafungin
|
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Favorable Outcome
Tijdsspanne: Day 28 post-treatment
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants With Unfavorable Outcome
Tijdsspanne: Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Death Unrelated to Fungal Infection
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Favorable Clinical Response
Tijdsspanne: Day 28 post-treatment
|
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
Tijdsspanne: Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Documented Eradication of Infecting Species
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Tijdsspanne: Baseline
|
Baseline
|
|
|
Duration of Stay at Liver Intensive Therapy Unit (LITU)
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
Baseline
|
|
|
Infecting Organisms by Species
Tijdsspanne: Baseline up to Day 14 post-treatment
|
Baseline up to Day 14 post-treatment
|
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Tijdsspanne: Baseline
|
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
Tijdsspanne: Baseline
|
Baseline
|
|
|
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Tijdsspanne: Baseline
|
Baseline
|
|
|
Number of Participants Who Received Water-based and Ethanol-based Formulation
Tijdsspanne: Baseline
|
Baseline
|
|
|
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Tijdsspanne: Baseline
|
Baseline
|
|
|
Percentage of Participants Who Received 200 mg Loading Dose
Tijdsspanne: Day 1
|
Day 1
|
|
|
Percentage of Participants Who Received 100 mg Dose on Day 2
Tijdsspanne: Day 2
|
Day 2
|
|
|
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Number of Participants With Other Dosing Patterns
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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
Tijdsspanne: Baseline
|
Baseline
|
|
|
Number of Serious Adverse Events (SAEs)
Tijdsspanne: Baseline up to Day 28 post-treatment
|
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)
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Number of Participants With Different Types of Drug-related Serious Adverse Events
Tijdsspanne: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2011
Primaire voltooiing (Werkelijk)
1 mei 2011
Studie voltooiing (Werkelijk)
1 mei 2011
Studieregistratiedata
Eerst ingediend
13 september 2010
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2010
Eerst geplaatst (Schatting)
15 september 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
16 april 2014
Laatste update ingediend die voldeed aan QC-criteria
25 maart 2014
Laatst geverifieerd
1 maart 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A8851028
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .