Acute Respiratory Tract Infection
Conditions
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTpoint-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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rates of respiratory failure and hospitalization | within 14 days after the diagnosis of acute respiratory infection |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients receiving target treatment | within 2 days |
| Duration of antibiotic treatment | within 14 days |
| Proportion of Patients Achieving Clinical Remission | within 3 days |
| Proportion of patients receiving an immediate antiviral treatment | within 1 day after the diagnosis |
| Proportion of patients receiving an immediate antiviral treatment by age, sex comorbidities, Immune status, season | within 1 day after the diagnosis |
| Proportion of patients receiving antibiotic treatment | within 2 days |
| Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration | within 3 days. |
| Proportion of patients who developed pneumonia | within 7 days |
| 28-day mortality rate | within 28 days |
| overall cost | within 28 days |
| Proportion of patients receiving antiviral treatment | within 2 days |
Countries
China
Contacts
Primary ContactFei Zhou, M.D.
Outcome results
None listed