Immunomodulatory Effect of Macrolides in Naturally Occurring Influenza Virus Infections in the Community
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time from recruitment to cessation of clinical illness
研究概览
简要总结
The investigators propose a double-blind randomised placebo-controlled study in naturally occurring influenza virus infections in the community setting to compare the impact of a short course of clarithromycin versus placebo, on the clinical course, viral shedding, immunomodulation, and the antimicrobial resistance pattern of respiratory bacterial carriage of the patients.
详细描述
Background: Influenza continues to pose an imminent threat to public health through seasonal epidemics and occasion pandemics with significant impact on morbidity and mortality. Increasing attention has also been paid in recent years to the potential benefit of immunomodulatory effect of macrolide antibiotics in the management of influenza virus infection.
Aims: To study the immunomodulatory effects of a short course of clarithromycin in naturally occurring influenza virus infection.
Design and subjects: The study is a double-blind, randomised controlled trial. One hundred adults aged 18-60 years will be recruited when they present with symptoms of acute respiratory infection within 48 hours of symptoms onset to university health clinics, and being tested positive with a QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test. Consented patients tested positive with the rapid test will receive their clinical consultation and prescriptions as indicated as usual, and being randomised to receive either clarithromycin (250mg) or placebo (in a ratio of 1:1) taken twice daily orally for three days. Blood specimen, nasal and throat swabs will be collected on the same day (day 1). They will be followed-up on day 4, day 7 and day 10 for further collection of nasal and throat swabs, and serum samples. A symptom diary will be kept by each participant for 10 days for monitoring the clinical course of the infection.
Study instruments: QuickVue/Sofia (Quidel Corp., San Diego, CA) rapid influenza test, symptom diary, blood specimen, nasal and throat swabs.
Interventions: Intervention group: clarithromycin; placebo group: placebo in identical packaging.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18-60
- •Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) to university health clinics within 48 hours of illness onset.
排除标准
- •Allergy to clarithromycin or any other macrolides or the ingredients in the tablets, which include microcrystalline cellulose, croscarmelose sodium, magnesium stearate and povidon will be excluded.
- •Patients with a history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication, or any underlying immunocompromised condition or receiving immunosuppressive agents will also be excluded.
研究组 & 干预措施
Intervention group
Intervention group: clarithromycin 1 tablet (250mg) twice daily for three days
干预措施: Clarithromycin 250 MG (Drug)
Placebo group
Placebo group: (identical-looking) placebo 1 tablet twice daily for three days.
干预措施: Placebos (Drug)
结局指标
主要结局
Time from recruitment to cessation of clinical illness
时间窗: 10 days
Defined as the time when all relevant clinical symptoms are resolved.
Time from recruitment to cessation of viral shedding
时间窗: 10 days
Defined as the time when no virus is detected by RT-PCR from both nasal and throat swabs.
次要结局
- Changes in blood immunity (Cytokine/chemokine and pro-inflammatory mediators)(7 days)
- Duration and severity of individual symptoms(10 days)
- Incidence of secondary complications(28 days)
- Health-related quality of life(28 days)
- Geometric mean rise in antibody titre against the infecting type or subtype of influenza virus(28 days)
- Change in the carriage rate of common respiratory bacterial pathogen(7 days)
研究者
Dr. Dennis Kai-Ming Ip
Clinical Associate Professor
The University of Hong Kong