Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. (ANTIBIONEED)
Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. A Randomized Cluster-controlled Trial.
Treatment of patients with febrile neutropenia (FN) attending Emergency Departments (EDs) relies on rapid antibiotic initiation in order to control a presumed infection. The choice of initial antibiotics is empirical and depends on patient's prior colonization or infection by multi-drug resistant pathogens (MDRPs) and risk stratification. Stratification of high-risk patients needing broad-spectrum antibiotics is debated. Thus, for non-specialist physicians, this choice may be challenging, leading to inappropriate initial antimicrobial regimens, potential risks for the patient and higher costs. Furthermore, international guidelines recommended to develop antibiotic stewardship programs and promoted an initial strategy based on escalation or de-escalation approaches, with early reassessment depending on patients' clinical course and microbiological results. Nevertheless, this interesting strategy may increase the level of complexity for the choice of the initial antibiotic regimen by non-specialist emergency physicians who are often the first prescribers in this context.
We developed an interactive computerized decision support app (CDSA) for initial antibiotic prescription and early revaluation in patients with FN. The first goal of this app is to assist non-specialized physicians in choosing initial antimicrobial regimen for patients with FN when they attend EDs. It uses an interactive algorithm based on international guidelines that takes into account patients' medical history and characteristics. Secondly, the app is also designed to propose an algorithm of antibiotic revaluation at day 3-4 for hospitalized patients, depending on patient clinical course, and biological and microbiological results. The revaluation suggests antimicrobial modification (escalation or de-escalation) or discontinuation and stopping rules with recommended duration of therapy also based on international guidelines.
We hypothesize that such a CDSA may improve the adherence to guidelines for the choice of initial antibiotic regimen for FN in the ED, favour early antibiotic reassessment for hospitalized patients, both decreasing the risk of treatment failure.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Olivier Peyrony
- Номер телефона: +33142494804
- Электронная почта: olivier.peyrony@aphp.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- age ≥ 18 years;
- reported or observed fever at arrival at the ED (≥38.3° C on one occasion or ≥38°C on two or more occasions within 1 h);
- chemotherapy-induced neutropenia (absolute neutrophil count ≤500/mm3 or ≤1000/mm3 and anticipated to decrease to fewer than 500/mm3 within 24 to 48 h).
Exclusion Criteria:
- refusal to participate;
- prior inclusion in the study for a previous episode of FN;
- any intravenous antibiotic administration during the preceding 72 h;
- renal failure requiring renal replacement therapy or with an estimated creatinine clearance of less than 20 ml/min;
- palliative status with life expectancy of less than three days;
- pregnancy, absence of health insurance, mental deficiency or inability to understand informed consent, no French speaking;
- patient with a microbiological documented infection when arriving at the ED (e.g. positive blood culture).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Control Group
As routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician.
|
The choice of the initial antibiotic regimen will be let to the discretion of the emergency physician
|
|
Экспериментальный: computerized decision support app (CDSA) Group
|
Implementation of an Computerized Decision support app (CDSA) : physician will use this app to help him in the antibiotic choice.
This app is an interactive algorithm based on international guidelines that takes into account patients' medical history and characteristics.
Secondly, the application is also designed to propose an algorithm of antibiotic revaluation at day 3 for hospitalized patients, depending on patient clinical course, and biological and microbiological results.
The revaluation suggests antimicrobial modification (escalation or de-escalation) or discontinuation and stopping rules with recommended duration of therapy also based on international guidelines.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Treatment failure
Временное ограничение: 7 days following inclusion
|
Treatment failure will be defined by any escalation of the assigned empirical initial antibiotic treatment (e.g. adjunction of aminoglycoside, glycopeptide or other anti-gram positive or any broadening of the beta-lactam spectrum) during the 7 days following inclusion, in relation with at least one of the following reasons:
|
7 days following inclusion
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of initial antibiotic regimen adhering to the international guidelines
Временное ограничение: at inclusion
|
at inclusion
|
|
|
Time to antibiotic initiation from patient triage at the emergency department (minutes)
Временное ограничение: at inclusion
|
at inclusion
|
|
|
Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;
Временное ограничение: at 3 days
|
at 3 days
|
|
|
Number of antimicrobial spectrum reductions
Временное ограничение: at 3 days
|
at 3 days
|
|
|
Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides
Временное ограничение: at inclusion
|
at inclusion
|
|
|
Number of days of Carbapenems, aminoglycosides and glycopeptides therapy
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Number of super-infections
Временное ограничение: up to 3 months
|
A super-infection will be defined as new, persistent or worsening symptoms and/or signs of infection associated with the isolation of a new pathogen (different, or different susceptibilities) or the development of a new site of infection;
|
up to 3 months
|
|
Number of super-infections due to clostridium difficile
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Number of colonization
Временное ограничение: up to 3 months
|
Colonization will be defined as isolation during or after therapy of Gram-negative bacteria resistant to the beta-lactam included in the empirical regimen, without symptoms or signs of infection
|
up to 3 months
|
|
Number of episodes of nephrotoxicity
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Number of episodes of other toxicities
Временное ограничение: up to 3 months
|
Toxicities will be defined according to the common terminology criteria for adverse events
|
up to 3 months
|
|
Occurrence of any complication during hospital stay or follow-up
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Number of re-hospitalizations due to a complication related to the initial infection
Временное ограничение: within 7 days of discharge
|
within 7 days of discharge
|
|
|
Antibiotic treatment duration
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Length of hospital stay
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Total 3-month costs
Временное ограничение: at 3 months
|
at 3 months
|
|
|
Number of deaths related to infection
Временное ограничение: at 3 months
|
Death related to infections will be defined according to the physician in charge of the patient
|
at 3 months
|
|
Number of in-hospital death
Временное ограничение: up to 3 months
|
up to 3 months
|
|
|
Survival status
Временное ограничение: at day 90
|
at day 90
|
|
|
Health related quality of life
Временное ограничение: at inclusion
|
Quality of life will be assessed using the EQ5D5L scale.
The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS).
The descriptive system has five dimensions.
Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems.
The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life.
The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
|
at inclusion
|
|
Health related quality of life.
Временное ограничение: at day 30
|
Quality of life will be assessed using the EQ5D5L scale.
The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS).
The descriptive system has five dimensions.
Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems.
The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life.
The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
|
at day 30
|
|
Health related quality of life.
Временное ограничение: at 3 months
|
Quality of life will be assessed using the EQ5D5L scale.
The EQ5D5L scale is composed of two parts: a descriptive system and the EQ Visual Analog Scale (EQ VAS).
The descriptive system has five dimensions.
Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems.
The descriptive system ranges from 1 to 25, the higher the score the worse the quality of life.
The score goes from VAS 0 to 100, the higher the VAS score the better the quality of life.
|
at 3 months
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- APHP210357
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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