Procalcitonin-guided Antibiotic Therapy During Severe Exacerbation of COPD Requiring Mechanical Ventilation: a Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- time to recovery
研究概览
简要总结
This study assess whether a procalcitonin guided antibiotic therapy can reduce significantly unnecessary antibiotic prescription during severe exacerbation of COPD requiring mechanical ventilation without compromising patients' outcome. The first group of patients will receive systematically empiric antibiotic therapy and the second group will receive antibiotics only if procalcitonin value is at or greater than 0.25 ng/ml.
详细描述
Recently, procalcitonin gained interest as the most reliable biomarker in predicting bacterial origin in low respiratory tract infections and sepsis.
Procalcitonin was shown to be non-inferior to standard guidelines in guiding antibiotic therapy during COPD exacerbation, without worsening patients' outcomes, and with a significant reduction in antibiotic exposure.
Its use to guide antibiotic treatment during COPD exacerbation may be more challenging because of the frequent colonization of the airways in patients with COPD, and thus it needs further evaluation.
Additionally, until today, no interventional studies evaluating procalcitonin protocol have been conducted in ventilated COPD patients.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 40 years old who consent to the study protocol
- •COPD diagnosis based on GOLD guidelines
排除标准
- •Patients who did not consent
- •Malignancy
- •Immunocompromised
- •Survival for at least 1 year is unlikely
- •Patients already enrolled in this study
研究组 & 干预措施
standard group
participants receive systematically empiric antibiotic therapy on admission with amoxicillin- acid clavulanic or levofloxacin in case of allergy
Procalcitonin group
participants receive antibiotics only if the procalcitonin value is at or greater than 0.25 ng/ml
干预措施: procalcitonin (Diagnostic Test)
结局指标
主要结局
time to recovery
时间窗: 28 days
defined by resolution of symptoms ( cough, sputum purulence and respiratory rate less than 25 breath per minute) and NIV withdrawal (normal pH for 24 consecutive hours after stopping NIV), for patients with home NIV investigators retain stabilization after returning to the same number of hours of NIV before current exacerbation and pH normalization for 24 consecutive hours
次要结局
- NIV failure(28 days)
- ICU length of say (days)(90 days)
- ICU mortality(28 days)
- Antibiotic exposure at day 90(90 days)
- Hospital readmission for another exacerbation at day 90(90 days)
- Hospital length of stay (days)(90 days)
研究者
Nejla Tilouche
principal investigator
University Hospital, Mahdia