EUCTR2018-003865-32-ES进行中（未招募）1 期
Efficacy, safety and pharmacokinetics profile of nebulized Aztreonam Lysine (AZLI) for prevention of Gram negative pneumonia in heavily colonized mechanically ventilated patients: AZLIS - AZLIS
Alejandro Rodriguez Oviedo - Critical Care Department – Hospital Universitario de Tarragona Joan XXIII0 个研究点目标入组 20 人开始时间: 2018年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years.
- •2. Patients under mechanical ventilation for more than 5 day
- •3. Patient with heavy colonization by Gram-negative microorganisms
- •4. No clinical suspicion of infections-related ventilator-associated complications (IVAC) according CDC criteria
- •5. Patients with ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.
- •6. Informed consent signed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Suspected of IVAC.
- •2. Patients with known hypersensitivity to Aztreonam.
- •3. Patients who received more than 48 hours of broad spectrum antibiotics.
- •4. Evidence of active mycobacterium infections, chronic pulmonary infection or bronchial obstruction.
- •5. Granulomatous disease, lung cancer or lung transplant.
- •6. Acute respiratory distress syndrome (ARDS)
- •7.Woman who is pregnant or breast-feeding while enrolled in this study.
- •8. Any medical condition which, in the opinion of the Investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study
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