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Not yet recruiting NCT07159230

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

No phase Interventional Acute Respiratory Tract Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: point-of-care multiplex PCR test.
Who it may be relevant to
Registry conditions: Acute Respiratory Tract Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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.

Overview

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 test point-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.

Primary outcome measures

  • The incidence rates of respiratory failure and hospitalization [Time frame: within 14 days after the diagnosis of acute respiratory infection]
Secondary outcome measures (12)
  • 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]
  • Proportion of Patients Achieving Clinical Remission [Time frame: within 3 days]
  • Proportion of Patients Achieving Clinical Remission [Time frame: within 7 days]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Xincheng District Hospital, Hohhot; Genghis Khan Community Health Service Center; East Str — Hohhot

Identifiers

NCT: NCT07159230 · 2024-KY-434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗