POS-ARI-ER Observational Study of Acute Respiratory Infections
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Data collection.
- Кому может быть актуально
- Состояния в реестре: Acute Respiratory Infection, Acute Respiratory Tract Infection. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия, Хорватия, Франция, Греция, Италия +5
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
Обзор
Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential, e.g. influenza and coronaviruses. The POS-ARI-ER study will focus on describing the different routine diagnostic and therapeutic practices in the work-up and treatment of ARI, as well as clinical outcomes across the patient population. In addition, POS-ARI-ER aims to characterise both the adult patient population with ARI presenting to acute hospital settings in Europe, and the aetiology of ARI in these patients.
Подробное описание
The POS-ARI-ER study is a perpetual, observational study (POS), designed to provide data for clinical characterisation of acute respiratory infections (ARIs) in adults presenting to hospital settings across Europe.
Establishing the etiological cause of ARI at the time of presentation is difficult with currently available diagnostic approaches. Improvements in diagnosis and strategies for use of targeted antibiotic and antiviral treatment strategies are needed to improve patient outcomes, and to reduce selection of antimicrobial resistance (AMR) and antiviral resistance. Recent advances in routine diagnostics in secondary care settings include molecular tests that can detect multiple pathogens simultaneously, and highly sensitive and specific point of care tests that can provide attending clinicians with rapid results. However, the implementation of these technologies into routine clinical practice within hospitals, and any impact on treatment decisions or patient outcomes, has not been widely evaluated.
The aim is to accurately characterise cases of ARIs presenting to acute hospital services, such as emergency departments and acute medical assessment units, in Europe.
Characterisation will focus on identifying the routine diagnostic methods (laboratory and point of care testing) and pharmacological interventions employed by different centres in patients presenting with ARI. Data will be collected using standardised report forms that capture clinical, laboratory and prescribing information. Participants will include those who require admission to hospital, as well as patients who are discharged the same day from the emergency department or acute medical assessment unit. In addition, a subset of participants will have single upper respiratory tract research sample (e.g. nose/throat swab) obtained at enrolment (within 24 hours), for pathogen detection by molecular methods.
Describing the variations in routine practice provides a foundation both to improve patient care through currently available approaches, as well as to inform areas of focus for development of new strategies.
Вмешательства
- Другое Data collection
Data collection from study participants to characterise diagnostic and therapeutic practices.
Первичные конечные точки
- Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations. [Срок оценки: Four years]
- Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators. [Срок оценки: Four years]
- Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe. [Срок оценки: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe. [Срок оценки: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe. [Срок оценки: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- All cause mortality in adults with community acquired ARI in acute hospital settings in Europe. [Срок оценки: Last day in hospital, at death or 28 days after admission, whichever comes first.]
Вторичные конечные точки (5)
- Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe. [Срок оценки: Four years]
- Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe. [Срок оценки: Four years]
- Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe. [Срок оценки: Four years]
- Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe. [Срок оценки: Four years]
- Aetiology of ARI in adults presenting to acute hospital settings in Europe. [Срок оценки: Four years]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Clinical suspicion of a new episode of acute respiratory tract infection, with onset in the last 10 days
- Patient presents to an emergency room or secondary care setting
- Informed consent is provided by patient or their legal representative
Критерии исключения
- Patient has been transferred from another hospital
- Patient admitted to hospital for >2 days at the time of enrolment
- Patient has been previously enrolled in the POS-ARI-ER study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 7 центров
- Craigavon Area Hospital — Craigavon
- NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital — Edinburgh
- Gateshead Health NHS Foundation Trust — Gateshead
- Liverpool University Hospitals NHS Foundation Trust — Liverpool
- Royal Free London NHS Foundation Trust - Royal Free Hospital — London
- Sheffield Teaching Hospitals NSH Foundation Trust — Sheffield
- South Tyneside and Sunderland NHS Foundation — Sunderland
Франция · 4 центра
- CHU Grenoble — Grenoble
- CHU Limoges — Limoges
- CHU Lyon — Lyon
- CHU de Tours — Tours
Румыния · 3 центра
- Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest — Bucharest
- Infectious and Tropical Diseases Hospital "Dr. Victor Babes" — Bucharest
- Cluj Napoca Infectious Disease Clinical Hospital — Cluj-Napoca
Нидерланды · 2 центра
- Noordwest Ziekenhuisgroep — Alkmaar
- Radboud University Medical Center — Nijmegen
Испания · 2 центра
- Hospital General Universitario de Alicante — Alicante
- Hospital Universitario Virgen Macarena — Seville
Бельгия · 1 центр
- Erasme Hospital — Brussels
Хорватия · 1 центр
- University Hospital for Infectious Diseases, Zagreb — Zagreb
Греция · 1 центр
- General University Hospital of Patras — Pátrai
Италия · 1 центр
- Azienda Ospedaliera Policlinico di Bari — Bari
Сербия · 1 центр
- General Hospital, Kragujevac — Kragujevac
Идентификаторы
NCT: NCT05814237 · ECRAID-Base POS-ARI-ER