Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07159230

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Location contact

Fei Zhou, M.D.

CONTACT

[email protected]

86 84206264

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • The condition is allowed to be treated in an outpatient clinic;
  • Signed informed consent.

Exclusion criteria

  • The doctor judges that the disease is serious and requires hospitalization;
  • New unclear consciousness;
  • Respiratory rate>=30 beats/min;
  • Hypoxemia or respiratory failure;
  • Heart rate> 125 beats/min;
  • Systolic blood pressure < 90 or diastolic blood pressure < 60 mmHg;
  • Known active tuberculosis;
  • Pregnant and lactating women;
  • Have participated in this study within 90 days;

Treatment and study plan

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.

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

  5. Proportion of patients receiving target treatment

    Time frame: within 2 days

  6. Proportion of patients receiving antibiotic treatment

    Time frame: within 7 days

  7. Proportion of patients receiving target treatment

    Time frame: within 7 days

  8. Proportion of patients receiving antibiotic treatment

    Time frame: within 14 days

  9. Proportion of patients receiving target treatment

    Time frame: within 14 days

  10. Duration of antibiotic treatment

    Time frame: within 14 days

  11. Proportion of Patients Achieving Clinical Remission

    Time frame: within 3 days

  12. Proportion of Patients Achieving Clinical Remission

    Time frame: within 7 days

  13. Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration

    Time frame: within 3 days.

  14. Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration

    Time frame: within 14 days

  15. Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration

    Time frame: within 28 days

  16. Proportion of patients who developed pneumonia

    Time frame: within 7 days

  17. Proportion of patients who developed pneumonia

    Time frame: within 14 days

  18. 28-day mortality rate

    Time frame: within 28 days

  19. overall cost

    Time frame: within 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Zhou, M.D.

CONTACT

[email protected]

86 84206264

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.