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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rates of respiratory failure and hospitalization | within 14 days after the diagnosis of acute respiratory infection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Zhou, M.D. | Contact | 86 84206264 | zryhyy_zf@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| 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 |
| Proportion of patients receiving antibiotic treatment | within 7 days |
| Proportion of patients receiving target treatment | within 7 days |
| Proportion of patients receiving antibiotic treatment | within 14 days |
| Proportion of patients receiving target treatment | within 14 days |
| Duration of antibiotic treatment | within 14 days |
| Proportion of Patients Achieving Clinical Remission | within 3 days |
| Proportion of Patients Achieving Clinical Remission | within 7 days |
| Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration | within 3 days. |
| Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration | within 14 days |
| Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration | within 28 days |
| Proportion of patients who developed pneumonia | within 7 days |
| Proportion of patients who developed pneumonia | within 14 days |
| 28-day mortality rate | within 28 days |
| overall cost | within 28 days |
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