Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
25. března 2014 aktualizováno: 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.
Přehled studie
Detailní popis
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Typ studie
Pozorovací
Zápis (Aktuální)
50
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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London, Spojené království, SE5 9RS
- Pfizer Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 90 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Anidulafungin
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A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Favorable Outcome
Časové okno: Day 28 post-treatment
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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.
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Day 28 post-treatment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants With Unfavorable Outcome
Časové okno: Day 28 post-treatment
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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.
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Day 28 post-treatment
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Percentage of Participants Who Died Due to All Causes
Časové okno: Baseline up to Day 28 post-treatment
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Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Death Attributable to Fungal Infection
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
|
|
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Percentage of Participants With Death Unrelated to Fungal Infection
Časové okno: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
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Percentage of Participants With Favorable Clinical Response
Časové okno: Day 28 post-treatment
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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.
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Day 28 post-treatment
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Percentage of Participants With Lack of Clinical Response
Časové okno: Day 28 post-treatment
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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.
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Day 28 post-treatment
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Percentage of Participants Requiring Change or Additional Antifungal Therapy
Časové okno: Baseline up to Day 28 post-treatment
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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).
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Oral Antifungal Started to Complete Therapy
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Documented Eradication of Infecting Species
Časové okno: Baseline
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Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
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Baseline
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Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
Časové okno: Baseline up to Day 28 post-treatment
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An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
Časové okno: Baseline up to Day 28 post-treatment
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A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
Časové okno: Baseline
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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).
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Baseline
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Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
Časové okno: Day 28 post-treatment
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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.
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Day 28 post-treatment
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Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy
Časové okno: Baseline up to Day 28 post-treatment
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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.
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Časové okno: Baseline
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Baseline
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Duration of Stay at Liver Intensive Therapy Unit (LITU)
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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|
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Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
Časové okno: 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).
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Baseline
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Percentage of Participants With Concomitant Bacterial or Viral Infection
Časové okno: Baseline
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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).
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Baseline
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Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Časové okno: Baseline
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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).
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Baseline
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Dose Changes for Immunosuppressant Drugs
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Časové okno: Baseline
|
Baseline
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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
Časové okno: 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).
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Baseline
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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
Časové okno: Baseline
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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).
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Baseline
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Number of Participants With Infection Sites as Per Microbiological Analysis
Časové okno: Baseline
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Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
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Baseline
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Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
Časové okno: Baseline
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Baseline
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Infecting Organisms by Species
Časové okno: Baseline up to Day 14 post-treatment
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Baseline up to Day 14 post-treatment
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Percentage of Participants With Prior Colonization With Candida by Species
Časové okno: Baseline
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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).
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Baseline
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Percentage of Participants With Prior Colonization With Candida by Colonization Index
Časové okno: Baseline
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Baseline
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Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Časové okno: Baseline
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Baseline
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|
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Number of Participants Who Received Water-based and Ethanol-based Formulation
Časové okno: Baseline
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Baseline
|
|
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Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Časové okno: Baseline
|
Baseline
|
|
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Percentage of Participants Who Received 200 mg Loading Dose
Časové okno: Day 1
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Day 1
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Percentage of Participants Who Received 100 mg Dose on Day 2
Časové okno: Day 2
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Day 2
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|
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Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Number of Participants With Other Dosing Patterns
Časové okno: Baseline up to Day 28 post-treatment
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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.
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Baseline up to Day 28 post-treatment
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Duration of Anidulafungin Therapy
Časové okno: Baseline
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Baseline
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Number of Serious Adverse Events (SAEs)
Časové okno: Baseline up to Day 28 post-treatment
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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.
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Baseline up to Day 28 post-treatment
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Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Number of Participants With Different Types of Drug-related Serious Adverse Events
Časové okno: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2011
Primární dokončení (Aktuální)
1. května 2011
Dokončení studie (Aktuální)
1. května 2011
Termíny zápisu do studia
První předloženo
13. září 2010
První předloženo, které splnilo kritéria kontroly kvality
13. září 2010
První zveřejněno (Odhad)
15. září 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
16. dubna 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. března 2014
Naposledy ověřeno
1. března 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- A8851028
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .