Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
25. marts 2014 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
London, Det Forenede Kongerige, SE5 9RS
- Pfizer Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Anidulafungin
|
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Favorable Outcome
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Unfavorable Outcome
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Death Unrelated to Fungal Infection
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Favorable Clinical Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants With Documented Eradication of Infecting Species
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Tidsramme: Baseline
|
Baseline
|
|
|
Duration of Stay at Liver Intensive Therapy Unit (LITU)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Baseline
|
|
|
Infecting Organisms by Species
Tidsramme: Baseline up to Day 14 post-treatment
|
Baseline up to Day 14 post-treatment
|
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Tidsramme: 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
Tidsramme: Baseline
|
Baseline
|
|
|
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Tidsramme: Baseline
|
Baseline
|
|
|
Number of Participants Who Received Water-based and Ethanol-based Formulation
Tidsramme: Baseline
|
Baseline
|
|
|
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Tidsramme: Baseline
|
Baseline
|
|
|
Percentage of Participants Who Received 200 mg Loading Dose
Tidsramme: Day 1
|
Day 1
|
|
|
Percentage of Participants Who Received 100 mg Dose on Day 2
Tidsramme: Day 2
|
Day 2
|
|
|
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
|
Number of Participants With Other Dosing Patterns
Tidsramme: 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
Tidsramme: Baseline
|
Baseline
|
|
|
Number of Serious Adverse Events (SAEs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2011
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
13. september 2010
Først indsendt, der opfyldte QC-kriterier
13. september 2010
Først opslået (Skøn)
15. september 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A8851028
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .