2023-509722-22-00招募中2 期
Nebulized Amikacine for Ventilator associated gram negative Pneumonia in ECMO veno-arterial patients: A randomized Pilot Study (NAVAP-ECMO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomisation and at least 12 hours after the last administration of inhaled amikacin
研究概览
简要总结
To show that the administration of inhaled amikacin for 5 days in addition to the usual antibiotic therapy in adult patients with documented Gram-negative Bacillus-positive pulmonary arterial disease undergoing VA-ECMO improves the bacterial eradication rate at D5 compared with the usual antibiotic therapy alone.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Circulatory assistance by ECMO veno-arterial for at least 24 hours prior to documentation of pneumonia
- •Invasive mechanical ventilation
- •Diagnostic suspicion of pneumonia based on suggestive criteria (presence of at least 2 of the following criteria): fever >
- •5°C, hyperleukocytosis >11 × 109 l-1 or leukopenia <4 × 109 l-1, purulent tracheobronchial secretions, altered oxygenation with the need to increase FiO2 on the ECMO or ventilator for the same SaO2 or PaO2 target, new or persistent pulmonary infiltrate(s) on chest X-ray in bed, or an image suggestive of pneumonia on a chest CT scan, or consolidation of an appearance suggestive of an infectious origin on lung ultrasound
- •Microbiological confirmation of gram-negative ventilator-associated pneumonia by quantitative culture on bronchoalveolar lavage (BAL, significance threshold > 104 CFU/ml) or protected distal sampling (PDP, significance threshold > 103 CFU/ml)
- •Probabilistic antibiotic therapy with piperacillin - tazobactam
- •Informed consent obtained from the patient or his/her trusted support person if unable to consent at the time of inclusion, or inclusion procedure in an emergency situation
- •Patient affiliated to a social security scheme (excluding AME)
排除标准
- •Known allergy to amikacin or another aminoglycoside
- •Patient moribund or with a high probability of death within 48 hours
- •Patient under legal protection (curatorship, guardianship or safeguard of justice)
- •Participating in another interventional clinical trial or within the exclusion period at the end of a previous study
- •Contraindications to the administration of amikacin
- •Contraindications to nebulisation
- •Intravenous antibiotic therapy started more than 72 hours before administration of the first dose of study treatment
- •Probabilistic venous antibiotic therapy other than piperacillin-tazobactam
- •Administration of inhaled antibiotics in the 7 days prior to inclusion
- •Positive pregnancy test for women of childbearing potential
- •Presence of HIV infection with CD4 count <200 cells/mm3 or fungal lung infection or pulmonary abscess or empyema
- •Presence of renal insufficiency with creatinine clearance < 15 ml/min, with the exception of patients receiving continuous renal purification or daily haemodialysis sessions as part of their intensive care treatment
结局指标
主要结局
Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomisation and at least 12 hours after the last administration of inhaled amikacin
Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomisation and at least 12 hours after the last administration of inhaled amikacin
次要结局
- Clinical cure rate, defined as the disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome, and correction of haematosis disorders, at D5
- Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5
- Difference between CPIS score at D5 and CPIS score at randomization
- Difference between ultrasound lung ventilation score at D5 and lung ventilation score at randomization
- Quantifying and analysing adverse events
- Pharmacokinetic analysis of plasma concentrations of piperacillin-tazobactam
- Measurement of the ratio of penetration into alveolar fluid (AUC alveolar fluid/AUC plasma) of piperacillin-tazobactam in patients undergoing VA-ECMO after 2 days of intravenous antibiotic therapy
研究者
Dr Pauline DUREAU
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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