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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Onset time<=7 days;

First visit;

Age>=18 years old;

Patients with acute upper respiratory tract infection with severe high-risk factors, or patients with acute lower respiratory tract infection;

Disqualifiers

The doctor judges that the disease is serious and requires hospitalization;

New unclear consciousness;

Respiratory rate>=30 beats/min;

Hypoxemia or respiratory failure;

Trial design

Design model

Parallel

Treatments tested in this trial

  • point-of-care multiplex PCR test

    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.

Treatment groups

16,868 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence rates of respiratory failure and hospitalization

Time frame
within 14 days after the diagnosis of acute respiratory infection

Secondary outcomes

1

Proportion of patients receiving an immediate antiviral treatment

Time frame
within 1 day after the diagnosis
2

Proportion of patients receiving an immediate antiviral treatment by age, sex comorbidities, Immune status, season

Time frame
within 1 day after the diagnosis
3

Proportion of patients receiving antiviral treatment

Time frame
within 2 days
4

Proportion of patients receiving antibiotic treatment

Time frame
within 2 days

Other outcomes

Sponsors and contacts

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