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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

16868 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intervention group

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.

Group Type EXPERIMENTAL

point-of-care multiplex PCR test

Intervention Type DIAGNOSTIC_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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No