Идёт набор NCT06998251

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

— Наблюдательное Pneumococcal Infections Respiratory Syncytial Virus (RSV) Infection Influenza Infection

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Pneumococcal Infections, Respiratory Syncytial Virus (RSV) Infection, Influenza Infection. Базовые параметры: 60 лет — 85 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: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The NoseSpn-Elderly study aims at characterizing the immune response in the upper respiratory tract in adults aged 60 and over diagnosed with a pneumonia due to a Streptococcus pneumoniae (Spn) infection. The immune response during the acute phase of the infection and after recovery will be compared to the immune response of asymptomatic Spn carriers as well as to the immune response of patients diagnosed with a viral respiratory infection (flu or respiratory syncytial virus (RSV)). The primary objective of this observational study is to quantify the inflammatory response in the nasal cavity and to correlate it with bacterial/viral load and with clinical parameters. The study also aims to compare the inflammatory response measured in the nose to that measured in the blood. Participants will have two study visits including a blood draw, several nasal samplings (nasal lining fluid and nasal cells) and a saliva sampling, one within 72 hours of their hospital admission and another one month later. Nasal lining fluid and saliva will be obtained every two or three days until discharge from the hospital or resolution of symptoms. During those visits, questions regarding symptoms will be asked.

Первичные конечные точки

Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay [Срок оценки: 1 month]

Вторичные конечные точки (12)

Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry [Срок оценки: 1 month]
Antibody titers in nasal cavity and blood by antigen-specific ELISA [Срок оценки: 1 month]
Bacterial load and viral load in nasal cavity by specific qPCR assay [Срок оценки: 1 month]
Levels of serum cytokines by multiplex assay [Срок оценки: 1 month]
Clinical outcome measure 1: pneumonia diagnostic [Срок оценки: 1 month]
Clinical outcome measure 2: CURB65 severity score [Срок оценки: 1 month]
Clinical outcome measure 3: nature and severity of symptoms (CAP score) [Срок оценки: 1 month]
Clinical outcome measure 4: number of days with fever [Срок оценки: 1 month]
Clinical outcome measure 5: number of days with oxygen [Срок оценки: 1 month]
Clinical outcome measure 6: highest FiO2 [Срок оценки: 1 month]
Clinical outcome measure 7: cardiac complication [Срок оценки: 1 month]
Clinical outcome measure 8: secondary bacterial infection [Срок оценки: 1 month]

Критерии участия

Критерии включения

Aged 60-85 years
Able to provide informed consent either independently or by a legal representative
Group 1 (Spn pneumonia patients): clinical and/or radiological signs of pneumonia
Group 1 (Spn pneumonia patients): positive Spn urinary antigen and/or blood culture and/or positive sputum test.
Group 2 (viral respiratory infection patients): clinical signs of a respiratory infection
Group 2 (viral respiratory infection patients): positive test for influenza or RSV
Group 3 (asymptomatic Spn-carriers): healthy without clinical signs of infection and no lower respiratory symptoms within the last month.