Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by Serum Procalcitonin in Acute Exacerbations of Chronic Obstructive Pulmonary Disease in Intensive Care
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The main objective is to show in patients hospitalized in intensive care for acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years
- •Documented or suspected clinically COPD according to the criteria of GOLD
- •In acute exacerbation
- •Suspect of lower respiratory tract infection
- •With or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
- •Admitted to the hospital for less than 48 hours
- •ICU Admission
- •Informed Consent signed by the patient or his representative
排除标准
- •Other than acute exacerbation etiology with or without pulmonary disease as suspected cause of ICU admission
- •Patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV seropositivity
- •Severe Acute Asthma
- •Moribund patient or a disease with an estimated survival time of less than three months
- •Therapeutic limitation Existence
- •minor patient or under guardianship or custody
- •Pregnant woman
- •Refusal to participate in the study
- •The inclusion of the subject in another biomedical research protocol in progress or for less than 30 days
研究组 & 干预措施
Anibiotic therapy guided with actual french recommandations
Guided by the antibiotic 2006 recommendations of the French consensus conference on anti-infective therapy of respiratory tract infections in low immuno-competent adult.
干预措施: Antibiotic therapy randomization (Other)
Anibiotic therapy guided with serum PCT value
Guided antibiotic therapy serum PCT at admission, revalued at day 1, day 3 and day 6 as long as PCT is not less than 0.1 ng / mL:
- PCT <0.1 ng / mL: no antibiotics
- 0.1 <PCT <0.25 ng / mL: antibiotic advised
- PCT> 0.25 ng / mL: highly recommended antibiotics
干预措施: Antibiotic therapy randomization (Other)
Anibiotic therapy guided with serum PCT value
Guided antibiotic therapy serum PCT at admission, revalued at day 1, day 3 and day 6 as long as PCT is not less than 0.1 ng / mL:
- PCT <0.1 ng / mL: no antibiotics
- 0.1 <PCT <0.25 ng / mL: antibiotic advised
- PCT> 0.25 ng / mL: highly recommended antibiotics
干预措施: Serum PCT dosage (Other)
结局指标
主要结局
mortality
时间窗: 3 month
次要结局
未报告次要终点