Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
25 марта 2014 г. обновлено: 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.
Обзор исследования
Подробное описание
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Тип исследования
Наблюдательный
Регистрация (Действительный)
50
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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London, Соединенное Королевство, SE5 9RS
- Pfizer Investigational Site
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 90 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants With Favorable Outcome
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Participants With Unfavorable Outcome
Временное ограничение: 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
|
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Percentage of Participants Who Died Due to All Causes
Временное ограничение: 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
Временное ограничение: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
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Percentage of Participants With Death Unrelated to Fungal Infection
Временное ограничение: 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
Временное ограничение: 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
|
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Percentage of Participants With Lack of Clinical Response
Временное ограничение: 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.
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Day 28 post-treatment
|
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Percentage of Participants Requiring Change or Additional Antifungal Therapy
Временное ограничение: 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).
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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
Временное ограничение: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
|
|
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Percentage of Participants With Documented Eradication of Infecting Species
Временное ограничение: Baseline
|
Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
|
Baseline
|
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Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
Временное ограничение: 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
Временное ограничение: 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.
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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
Временное ограничение: 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
Временное ограничение: 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.
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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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: Baseline
|
Baseline
|
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Duration of Stay at Liver Intensive Therapy Unit (LITU)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
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Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Временное ограничение: 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).
|
Baseline
|
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Dose Changes for Immunosuppressant Drugs
Временное ограничение: Baseline up to Day 28 post-treatment
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
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Number of Participants With Infection Sites as Per Microbiological Analysis
Временное ограничение: Baseline
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Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
|
Baseline
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Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
Временное ограничение: Baseline
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Baseline
|
|
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Infecting Organisms by Species
Временное ограничение: 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
Временное ограничение: 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
|
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Percentage of Participants With Prior Colonization With Candida by Colonization Index
Временное ограничение: Baseline
|
Baseline
|
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Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Временное ограничение: Baseline
|
Baseline
|
|
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Number of Participants Who Received Water-based and Ethanol-based Formulation
Временное ограничение: Baseline
|
Baseline
|
|
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Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Временное ограничение: Baseline
|
Baseline
|
|
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Percentage of Participants Who Received 200 mg Loading Dose
Временное ограничение: Day 1
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Day 1
|
|
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Percentage of Participants Who Received 100 mg Dose on Day 2
Временное ограничение: Day 2
|
Day 2
|
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Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Временное ограничение: Baseline up to Day 28 post-treatment
|
Baseline up to Day 28 post-treatment
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Number of Participants With Other Dosing Patterns
Временное ограничение: 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
Временное ограничение: Baseline
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Baseline
|
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Number of Serious Adverse Events (SAEs)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: Baseline up to Day 28 post-treatment
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Baseline up to Day 28 post-treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 февраля 2011 г.
Первичное завершение (Действительный)
1 мая 2011 г.
Завершение исследования (Действительный)
1 мая 2011 г.
Даты регистрации исследования
Первый отправленный
13 сентября 2010 г.
Впервые представлено, что соответствует критериям контроля качества
13 сентября 2010 г.
Первый опубликованный (Оценивать)
15 сентября 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
16 апреля 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 марта 2014 г.
Последняя проверка
1 марта 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- A8851028
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .