NCT01925066已完成2 期
Optimal Two-Stage Phase 2 Study of Efficacy and Pharmacokinetics of Aerosolized Vancomycin in Methicillin-Resistant Staphylococcus Aureus Pneumonia Under Mechanical Ventilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- clinical cure rate
研究概览
简要总结
The purpose of this study is to determine whether aerosolized vancomycin is effective in the treatment of methicillin-resistant staphylococcus aureus pneumonia under mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nosocomial or severe community-acquired pneumonia due to Methicillin-Resistant Staphylococcus aureus
- •Must be mechanically ventilated in intensive care unit
排除标准
- •Non-bacterial pneumonia, such as viral, fungal, tuberculosis infections
- •Underlying respiratory condition: bronchiectasis, post-tuberculosis, chronic obstructive pulmonary disease or asthma
- •Complicated pneumonia, such as empyema, parapneumonic effusion requiring chest tube or drainage
- •Already or previous treated with intravenous vancomycin (Not pneumonia)
- •Adverse reaction due to inhaled ventolin before treatment of aerosolized vancomycin
- •Hypersensitivity of vancomycin or glycopeptide antibiotics
- •Positive culture of Enterococcus in respiratory specimen
- •Pregnant or Breast-feeding patient
- •Immunocompromised hosts: more than 1mg/kg of corticosteroid users for more than 3 months, transplantation recipients, AIDS patients
- •Another aerosolized antibiotics within 48 hours of study enrollment
- •Not adherent to mechanical ventilation protocol of this study
- •Not arterial line monitoring
- •Vancomycin minimum inhibitory concentration >= 2㎍/㎖ of cultured Staphylococcus aureus
研究组 & 干预措施
Aerosolized Vancomycin
Experimental
干预措施: Vancomycin (Drug)
结局指标
主要结局
clinical cure rate
时间窗: within the first 30 days after treatment
次要结局
- the peak level of serum vancomycin level(on 3rd and 5th days after treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple SclerosisMultiple Sclerosis (MS)NCT02166021Dimitrios Karussis48
终止
4 期
Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)Clostridium Difficile InfectionClostridium Difficile Infection RecurrenceNCT04000555University of South Florida26
终止
2 期
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.Advanced or Metastatic Gastric CancerAdvanced or Metastatic Gastroesophageal Junction CarcinomaNCT05188209Lepu Biopharma Co., Ltd.6
已完成
1 期
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisNCT01085760Mayo Clinic35
进行中（未招募）
1 期
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT05488314Janssen Research & Development, LLC57