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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16,868
- 试验地点
- 1
- 主要终点
- The incidence rates of respiratory failure and hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
intervention group
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.
干预措施: point-of-care multiplex PCR test (Diagnostic Test)
control group
patients in the control group will take the routine tests and receive anti-infective treatment according to clinical assessment and guideline.
结局指标
主要结局
The incidence rates of respiratory failure and hospitalization
时间窗: within 14 days after the diagnosis of acute respiratory infection
次要结局
- 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 an immediate antiviral treatment(within 1 day after the diagnosis)
- 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 7 days)
- Proportion of patients requiring unscheduled healthcare encounters or referrals due to clinical deterioration(within 28 days)
- Proportion of patients who developed pneumonia(within 14 days)
- 28-day mortality rate(within 28 days)
- overall cost(within 28 days)
- Proportion of Patients Achieving Clinical Remission(within 3 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 2 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 who developed pneumonia(within 7 days)
研究者
Bin Cao
Professor
Capital Medical University