Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
25 marca 2014 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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 studiów
Obserwacyjny
Zapisy (Rzeczywisty)
50
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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London, Zjednoczone Królestwo, SE5 9RS
- Pfizer Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 90 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants With Favorable Outcome
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants With Unfavorable Outcome
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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 Favorable Clinical Response
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: Baseline
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Baseline
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Duration of Stay at Liver Intensive Therapy Unit (LITU)
Ramy czasowe: 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 Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
Ramy czasowe: Baseline
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
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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
Ramy czasowe: Baseline
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
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Baseline
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Infecting Organisms by Species
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
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Baseline
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Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Ramy czasowe: Baseline
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Baseline
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Number of Participants Who Received Water-based and Ethanol-based Formulation
Ramy czasowe: Baseline
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Baseline
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Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Ramy czasowe: Baseline
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Baseline
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Percentage of Participants Who Received 200 mg Loading Dose
Ramy czasowe: Day 1
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Day 1
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Percentage of Participants Who Received 100 mg Dose on Day 2
Ramy czasowe: Day 2
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Day 2
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Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline
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Baseline
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Number of Serious Adverse Events (SAEs)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lutego 2011
Zakończenie podstawowe (Rzeczywisty)
1 maja 2011
Ukończenie studiów (Rzeczywisty)
1 maja 2011
Daty rejestracji na studia
Pierwszy przesłany
13 września 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 września 2010
Pierwszy wysłany (Oszacować)
15 września 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
16 kwietnia 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 marca 2014
Ostatnia weryfikacja
1 marca 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- A8851028
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .