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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108891
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory tract infection

Interventions

Intervention group:Based on routine testing, provide multiplex PCR testing (POCT) methods
Control group:Conduct routine tests based on the existing conditions of the community hospital and provide corresponding anti-infection treatment according to the guidelines.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Onset time=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

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

MeasureTime frame
The incidence rates of respiratory failure and hospitalization within 14 days;

Secondary

MeasureTime frame
Proportion of patients receiving an immediate antiviral treatment ;Proportion of patients receiving an immediate antiviral treatment by age, gender, comorbidities, Immune status, season;Proportion of patients receiving an immediate antibiotic prescription;Proportion of patients receiving an immediate antibiotic prescription by age, gender, comorbidities, Immune status, season;Proportion of patients receiving an immediate target treatment;Proportion of patients receiving an immediate target treatment by age,gender, comorbidities, Immune status, season;Proportion of patients receiving antiviral treatment within 2 days;Proportion of patients receiving antibiotic treatment within 2 days;Proportion of patients receiving target treatment within 2 days;Proportion of patients receiving antibiotic treatment within 7 days;Proportion of patients receiving target treatment within 7 days;Proportion of patients receiving antibiotic treatment within 14 days;Proportion of patients receiving target treatment within 14 days;Duration of antibiotic treatment within 14 days;Proportion of Patients Achieving Clinical Remission by Day 3;Proportion of Patients Achieving Clinical Remission by Day 7;Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration within 3 days.;Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration within 7 days;Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration within 14 days;Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration within28 days;Proportion of patients who developed pneumonia within 7 days;Proportion of patients who developed pneumonia within 14 days;28-day mortality rate;overall cost;

Countries

China

Contacts

Public ContactBin Cao

China-Japan Friendship Hospital

caobin_ben@163.com+86 139 1131 8339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026