NCT07159230

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,868

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Jan 2028

First Submitted

Initial submission to the registry

September 4, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

September 4, 2025

Last Update Submit

September 4, 2025

Conditions

Acute Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

  • The incidence rates of respiratory failure and hospitalization

    within 14 days after the diagnosis of acute respiratory infection

Secondary Outcomes (19)

  • 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 antiviral treatment

    within 2 days

  • Proportion of patients receiving antibiotic treatment

    within 2 days

  • Proportion of patients receiving target treatment

    within 2 days

  • +14 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Diagnostic Test: point-of-care multiplex PCR test

control group

NO INTERVENTION

patients in the control group will take the routine tests and receive anti-infective treatment according to clinical assessment and guideline.

Interventions

point-of-care multiplex PCR testDIAGNOSTIC_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.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Central Study Contacts

Fei Zhou, M.D.

CONTACT

86 84206264zryhyy_zf@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 8, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)