NCT03058718已完成不适用
Effectiveness of Procalcitonin-Guided Antibiotic Therapy in Acute Exacerbations of Bronchiectasis: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Antimicrobial prescription rate
研究概览
简要总结
To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bronchiectasis was diagnosed by high-resolution computed tomography based on the criteria published by McShane PJ et al.
- •Acute exacerbations of bronchiectasis.
- •Aged >= 18 years.
- •Procalcitonin been detected after admission.
排除标准
- •Associated with chronic obstructive pulmonary disease.
- •Associated with asthma.
- •Traction bronchiectasis caused by pulmonary fibrosis.
- •Rule out other possible cause procalcitonin increased diseases such as cancer, connective tissue disease, active tuberculosis, chronic liver disease and respiratory system than the bacterial infection.
- •Clinical data were incomplete.
- •Can not follow up with the person.
研究组 & 干预措施
Standard antibiotic therapy group
Active Comparator
The application of antibiotics is given to patiens according to the doctor's experience.
干预措施: Clinical Experience (Other)
Procalcitonin-guided antibiotic treatment group
Experimental
Patients were divided into 2 subgroups:
- No infection group (including patients with procalcitonin<0.1 ng/ml at enrollment, and patients with 0.1 ng/ml ≤procalcitonin ≤0.25 ng/ml at enrollment who are with stable respiratory and hemodynamics, and without serious complications) : the group is not given the application of antibiotics.
- Infection group (including patients with procalcitonin>0.25 ng/ml at the time of enrollment, and patients with 0.1 ng/ml ≤ procalcitonin≤0.25 ng/ml at enrollment who have severe disease, unstable hemodynamics, and severe complications or intensive care unit treatment): the group is given the application of antibiotics. According to the guidelines for severe sepsis / septic shock treatment, the standard for discontinuation of antimicrobial agents: If the procalcitonin level falls below <0.1 ng/ml or more than 80%, compared with the baseline before enrollment, it is recommended to discontinue the antimicrobial agent.
干预措施: Procalcitonin (Other)
结局指标
主要结局
Antimicrobial prescription rate
时间窗: 14 days
Number of days of antimicrobial application
时间窗: 14 days
The number of days in hospital
时间窗: 14 days
次要结局
- mortality rate(14 days)
- Effective rate of clinical treatment(14 days)
- Quality of life score(6 months)
- Adverse reaction rate(14 days)
- Bacterial resistance rate(14 days)
- The incidence of complications(14 days)
- fungal infection rate(14 days)
- The proportion of patients with at least once acute exacerbation in 6 months(6 months)
研究者
Qian Qi
assistant director
Qilu Hospital of Shandong University
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