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

Capital Medical University

Status: Not yet enrolling

Conditions: Acute Respiratory Tract Infection

Treatments: Diagnostic Test: point-of-care multiplex PCR test

Study type: Interventional

Funder types: Other

Identifiers

NCT07159230

2024-KY-434

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16,868 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,868 participants in 2 patient groups

intervention group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: point-of-care multiplex PCR test

control group

No Intervention group

Description:

patients in the control group will take the routine tests and receive anti-infective treatment according to clinical assessment and guideline.