Acute Respiratory Tract InfectionNCT07159230
PCOT for Outpatients With Acute Respiratory Tract Infection at Risk of Severe Disease in Primary Healthcare
A study testing point-of-care multiplex PCR test in people with Acute Respiratory Tract Infection, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- point-of-care multiplex PCR test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,868 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Known active tuberculosis;
- Pregnant and lactating women;
- Have participated in this study within 90 days;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
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
Fei Zhou, M.D., 86 84206264, zryhyy_zf@sina.com
About this study
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.
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.
Read the 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.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- point-of-care multiplex PCR test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rates of respiratory failure and hospitalization
Measured: within 14 days after the diagnosis of acute respiratory infection
Secondary outcomes (19)
Proportion of patients receiving an immediate antiviral treatment
Measured: within 1 day after the diagnosis
Proportion of patients receiving an immediate antiviral treatment by age, sex comorbidities, Immune status, season
Measured: within 1 day after the diagnosis
Proportion of patients receiving antiviral treatment
Measured: within 2 days
Proportion of patients receiving antibiotic treatment
Measured: within 2 days
Proportion of patients receiving target treatment
Measured: within 2 days
Proportion of patients receiving antibiotic treatment
Measured: within 7 days
Proportion of patients receiving target treatment
Measured: within 7 days
Proportion of patients receiving antibiotic treatment
Measured: within 14 days
Proportion of patients receiving target treatment
Measured: within 14 days
Duration of antibiotic treatment
Measured: within 14 days
Proportion of Patients Achieving Clinical Remission
Measured: within 3 days
Proportion of Patients Achieving Clinical Remission
Measured: within 7 days
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Measured: within 3 days.
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Measured: within 14 days
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Measured: within 28 days
Proportion of patients who developed pneumonia
Measured: within 7 days
Proportion of patients who developed pneumonia
Measured: within 14 days
28-day mortality rate
Measured: within 28 days
overall cost
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159230
- Sponsor's protocol ID
- 2024-KY-434
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07159230
- Acronym / sponsor ID
- 2024-KY-434
- Conditions
- Acute Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16,868 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Diagnostic Test: point-of-care multiplex PCR testcommunity 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| point-of-care multiplex PCR testcommunity 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 | intervention group |
Primary outcome
The incidence rates of respiratory failure and hospitalization
Time frame: within 14 days after the diagnosis of acute respiratory infection
19 secondary outcomes
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
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 3 days.
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 14 days
Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration
Time frame: within 28 days
Proportion of patients who developed pneumonia
Time frame: within 7 days
Proportion of patients who developed pneumonia
Time frame: within 14 days
28-day mortality rate
Time frame: within 28 days
overall cost
Time frame: within 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing point-of-care multiplex PCR test in people with Acute Respiratory Tract Infection, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Zhou, M.D. (86 84206264, zryhyy_zf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of respiratory failure and hospitalization (time frame: within 14 days after the diagnosis of acute respiratory infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.