NCT05689229已完成3 期
Aerosolized Versus Intravenous Colistin-based Antimicrobial Regimens in Hospitalized COVID-19 Patients With Bacterial Coinfection: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Microbial eradication
研究概览
简要总结
Secondary bacterial pathogen infection has been demonstrated to aggravate COVID-19 clinical outcomes. Bacterial infections acquired during a hospital stay are likely resistant to several antimicrobial medicines, making COVID-19 patient management difficult. As a result, it is believed that aerosolized colistin might be a viable choice for treating secondary bacterial infections caused by gram-negative resistant strains in individuals who also have COVID-19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Covid-19 patients with secondary gram-negative bacterial infections
排除标准
- •Patients with resistant bacterial strains to polymyxins
- •patients less than 18 years
研究组 & 干预措施
Colistin IV
Active Comparator
干预措施: Colistin (Drug)
Colistin Aerosolized
Active Comparator
干预措施: Colistin (Drug)
结局指标
主要结局
Microbial eradication
时间窗: 10 days
Mortality
时间窗: 30 days
次要结局
- Nephrotoxicity(10 days)
研究者
Hasnaa Osama
Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University
Beni-Suef University
研究点 (1)
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