Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- cytokine and inflammatory responses
研究概览
简要总结
Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.
详细描述
Objectives: (1) We aim to investigate the anti-inflammatory effects of macrolide treatment in patients with influenza LRTI and the impact on viral clearance. (2) To investigate the impact of macrolide treatment on influenza symptom and disease resolution.
Design: A randomized, open-label, multicenter study.
Settings: Acute medical facilities in 3 general public hospitals in Hong Kong.
Subjects, Sampling and Intervention: Adult (>/=18 years) patients hospitalized for virologically confirmed influenza LRTI who fulfill the inclusion/exclusion criteria will be randomized to receive (1) azithromycin 500 mg p.o. for 5 days (in addition to antiviral, as part of usual care), or (2) no azithromycin (ie, antiviral alone, part of usual care) after informed consent. Serial blood samples will be collected for cytokine/inflammatory response assays. Serial nasopharyngeal swabs will be collected to assess for viral clearance. Symptoms, clinical progress, radiography and adverse events will be monitored.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established influenza A or B infection by virologic tests
- •age >/=18 years
- •present within 4 days from illness onset
- •clinical evidence of LRTI and require hospital care
- •require antiviral (oseltamivir) treatment
- •able to provide written, informed consent.
排除标准
- •patients on immunosuppressants
- •pregnant or lactating woman
- •known hepatic failure, end-stage renal failure, cardiac arrhythmia (e.g. prolonged corrected QT interval >450 msec)
- •known contraindications to azithromycin (e.g. allergic reaction)
- •lack of consent for study.
研究组 & 干预措施
Macrolide treatment
Azithromycin 500 mg daily for 5 days
干预措施: Macrolide treatment (Drug)
结局指标
主要结局
cytokine and inflammatory responses
时间窗: within 10 days post-intervention
Serial measurements of selected cytokines/chemokines (e.g. interleukin-6, CXCL8) and proinflammatory molecules (e.g. DAMPs)
次要结局
- viral clearance(within 10 days post-intervention)
研究者
Nelson Lee
Professor
Chinese University of Hong Kong