NCT03452826已完成不适用
Combined Use of a Respiratory Broad Panel MULTIplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia: a Multicentre, Parallel-group, Open-label, Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 2
- 主要终点
- The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy
研究概览
简要总结
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin (intervention) in severe CAP, as compared to a conventional strategy (control).
A multicentre, parallel-group, open-label, randomized controlled trial. The primary assessment criterion est the number of antibiotic-free days at 28 days
详细描述
Randomization is performed immediately after the inclusion.
- In the intervention arm, a broad panel respiratory mPCR is performed on a lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum), collected before the 12th hour following inclusion.
- In both arms, an additional lower respiratory tract sample (bronchoalveolar lavage fluid or tracheal aspirate, otherwise sputum) is collected for biological studies and banking.
- In the intervention arm, an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results, including the mPCR results, and the procalcitonin value. This algorithm is applied as soon as possible (before the 24th hour following inclusion if possible).
- In the control arm, initial antibiotic therapy is maintained, according to guidelines.
- In both arms, after 72 hours of antibiotic therapy, ICU physicians are advised to use procalcitonin (values and kinetics) to guide antibiotic therapy discontinuation, with a recommended total duration of 7 days, unless otherwise indicated.
- In both arms, a switch to oral therapy is encouraged
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adults (≥18 years) with CAP admitted to the ICU since 18 hours or less; the diagnosis of pneumonia includes two clinical criteria among a temperature > 37.8°C, tachypnea (respiratory rate > 25/min), chest pain, cough, expectoration, localized crackles, with or without signs of pleural effusion, pulse oximetry less than 92% while breathing room air, and a newly-appeared parenchymal infiltrate; the pneumonia is community-acquired if the time between hospital admission and ICU referral is below or equal to 48 hours.
- •Informed consent or emergency procedure.
排除标准
- •Pregnancy;
- •Congenital immunodeficiency;
- •HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
- •Acute hematologic malignancy;
- •Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
- •Immunosuppressive drugs within the previous 30 days, including anti-cancer chemotherapy and anti-rejection drugs for organ/bone marrow transplant
- •Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days;
- •chronic obstructive pulmonary disease (COPD) with previous history of colonization/infection with Pseudomonas aeruginosa;
- •Tracheostomy;
- •Diffuse bronchiectasis, cystic fibrosis;
- •Aspiration pneumonia;
- •Moribund patient or death expected from underlying disease during the current admission;
- •Patient deprived of liberty or under legal protection measure;
- •Participation in another interventional trial.
结局指标
主要结局
The effectiveness of a management combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin in severe CAP, as compared to a conventional strategy
时间窗: Day 28
the number of antibiotic free days at D28, which corresponds to the number of days alive without any at Day 28.
次要结局
- Number of organ-failure free days (based on SOFA) at D28(Day 28)
- Number of defined daily dose (DDD) per 100 patient days of broad- and narrow-spectrum antibiotics(Day 28)
- Antibiotics duration at D28(Day 28)
- Incidence rates of bacterial superinfections at D28(Day 28)
- Duration of ICU and hospital stay(Day 90)
- Mortality at 28 (D28) and 90 days (D90);(Day 28 and day 90)
- Incidence rates of colonization/infection with multidrug resistant bacteria and Clostridium difficile infections at D28(Day 28)
- Incremental / decremental cost effectiveness ratio in cost per treatment success (90-day composite of all-cause death and infection recurrence).(Day 90)
- Euroquol questionary (EQ-5D-3L)(Day 90)
- Cost of the total hospital admissions (including 90-day repeated admissions), ICU costs, cost of the microbiological diagnostic workup;(Day 90)
- Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference(Day 28)
- To assess the operational values of the broad panel mPCR Film Array for the diagnosis of ventilator associated pneumonia (in the intervention group only).(Day 28)
- Incidence rates of relapse (same pathogen) or reinfection (another pathogen) at D28(Day 28)
研究者
研究点 (2)
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