Набор скоро начнётся NCT07159230

PCOT for Outpatients With Acute Respiratory Tract Infection at Risk of Severe Disease in Primary Healthcare

Без фазы С лечением Acute Respiratory Tract 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: В протоколе указаны: point-of-care multiplex PCR test.
Кому может быть актуально: Состояния в реестре: 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: Китай
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

Point-of-care Multiplex PCR Test for Outpatients With Acute Respiratory Tract Infection at Risk of Severe Disease in Primary Healthcare: a Pragmatic Cluster-randomised Controlled Trial.

Обзор

This study aims to evaluate the clinical value of point-of-care multiplex PCR testing (POCT) in guiding early diagnosis and target treatment for acute respiratory infections in primary healthcare settings.

Подробное описание

Advanced age, comorbidities, and immunosuppression are high-risk factors of severe disease in acute respiratory infections. In China, the exacerbation of population aging and increasing number of individuals with chronic comorbidities have aggravated the severity of the issue and posed a serious challenge to public health. However, insufficient pathogen diagnostic capabilities in primary healthcare prevents patients at high risk of severe disease from receiving timely and targeted treatments, potentially leading to delays in clinical management, adverse prognoses and increased economic burdens. This study aims to evaluate the clinical value of point-of-care multiplex PCR testing (POCT) in guiding early diagnosis and target treatment for acute respiratory infections in primary healthcare settings.

Вмешательства

Диагностический тест point-of-care multiplex PCR test
community health care center in intervention group were provided with point-of-care multiplex PCR test (POCT) plus routine test. POCT testing was recommended for all enrolled patients presenting with acute respiratory infections who meet the predefined inclusion criteria. The therapeutic interventions were determined by health-care workers on the basis of POCT result, clinical assessment and guideline.

Первичные конечные точки

The incidence rates of respiratory failure and hospitalization [Срок оценки: within 14 days after the diagnosis of acute respiratory infection]

Вторичные конечные точки (12)

Proportion of patients receiving an immediate antiviral treatment [Срок оценки: within 1 day after the diagnosis]
Proportion of patients receiving an immediate antiviral treatment by age, sex comorbidities, Immune status, season [Срок оценки: within 1 day after the diagnosis]
Proportion of patients receiving antiviral treatment [Срок оценки: within 2 days]
Proportion of patients receiving antibiotic treatment [Срок оценки: within 2 days]
Proportion of patients receiving target treatment [Срок оценки: within 2 days]
Proportion of patients receiving antibiotic treatment [Срок оценки: within 7 days]
Proportion of patients receiving target treatment [Срок оценки: within 7 days]
Proportion of patients receiving antibiotic treatment [Срок оценки: within 14 days]
Proportion of patients receiving target treatment [Срок оценки: within 14 days]
Duration of antibiotic treatment [Срок оценки: within 14 days]
Proportion of Patients Achieving Clinical Remission [Срок оценки: within 3 days]
Proportion of Patients Achieving Clinical Remission [Срок оценки: within 7 days]

Критерии участия

Критерии включения

Onset time<=7 days;
First visit;
Age>=18 years old;
Patients with acute upper respiratory tract infection with severe high-risk factors, or patients with acute lower respiratory tract infection;
The condition is allowed to be treated in an outpatient clinic;
Signed informed consent.