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

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.

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

1. The doctor judges that the disease is serious and requires hospitalization;
2. New unclear consciousness;
3. Respiratory rate>=30 beats/min;
4. Hypoxemia or respiratory failure;
5. Heart rate> 125 beats/min;
6. Systolic blood pressure < 90 or diastolic blood pressure < 60 mmHg;
7. Known active tuberculosis;
8. Pregnant and lactating women;
9. Have participated in this study within 90 days;