EUCTR2008-000906-35-FR进行中（未招募）1 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 712
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
- •The main inclusion criteria are:
- •Males and non-pregnant, non-lactating females, 18 years of age or older
- •Intubated and mechanically-ventilated
- •Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph and presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions
- •CPIS of at least 6
- •At least two risk factors for multi-drug resistant organisms
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The main exclusion criteria are:
- •Known local or systemic hypersensitivity to amikacin, other aminoglycosides, or components of the amikacin sulfate solution for inhalation
- •Has received antibiotic therapy for Gram-negative pneumonia for greater than 24 hours at the time of randomization
- •Primary lung cancer or another malignancy metastatic to the lungs or other known endobronchial obstructions
- •Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3, or invasive fungal infection of the lung
- •Has had a stroke within five days
- •Burns greater than 40% of total body surface area
- •Screening serum creatinine > 2 mg/dL (177 µmol/L)
- •Neutropenia (Screening ANC < 10^3 neutrophils/mm3), stem cell transplant
- •Has been on mechanical ventilation for > 28 days
- •Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
- •Presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and follow-up could be completed
- •Positive serum ß-hCG pregnancy test
研究者
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