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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16,868
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.
Xincheng District Hospital, Hohhot; Genghis Khan Community Health Service Center; East Street & West Street Sub-district Community Health Service Center; East Yingxin Road Community Health Service Center and so on
Hohhot, Inner Mongolia, China
The incidence rates of respiratory failure and hospitalization
Time frame: within 14 days after the diagnosis of acute respiratory infection
Proportion of patients receiving an immediate antiviral treatment
Time frame: within 1 day after the diagnosis
Proportion of patients receiving an immediate antiviral treatment by age, sex comorbidities, Immune status, season
Time frame: within 1 day after the diagnosis
Proportion of patients receiving antiviral treatment
Time frame: within 2 days
Proportion of patients receiving antibiotic treatment
Time frame: within 2 days
Proportion of patients receiving target treatment
Time frame: within 2 days
Proportion of patients receiving antibiotic treatment
Time frame: within 7 days
Proportion of patients receiving target treatment
Time frame: within 7 days
Proportion of patients receiving antibiotic treatment
Time frame: within 14 days
Proportion of patients receiving target treatment
Time frame: within 14 days
Duration of antibiotic treatment
Time frame: within 14 days
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Proportion of Patients Achieving Clinical Remission
Time frame: within 3 days
Proportion of Patients Achieving Clinical Remission
Time frame: within 7 days
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 3 days.
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 14 days
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 28 days
Proportion of patients who developed pneumonia
Time frame: within 7 days
Proportion of patients who developed pneumonia
Time frame: within 14 days
28-day mortality rate
Time frame: within 28 days
overall cost
Time frame: within 28 days