NCT01078779Unknown2 期
A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 1,516
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed influenza-like illness
研究概览
简要总结
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 -65
- •Have the ability to provide informed consent
- •If a woman of child-bearing potential, willing to use contraception for the period of the trial
排除标准
- •Acute influenza-like illness at screening
- •History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease
- •Pregnancy or breast feeding
- •Current use of medication with known serious hepatotoxic effects
- •Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin
- •Current severe depression (as indicated by current use of antidepressant medication)
- •Known serious retinal disease
- •Current or recent (within the past 30 days) participation in any other clinical intervention trial.
- •Known G6PD deficiency
- •Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening
研究组 & 干预措施
Chloroquine
Experimental
干预措施: Chloroquine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Laboratory-confirmed influenza-like illness
时间窗: 12 weeks
次要结局
- Serologically-confirmed influenza infection (symptomatic or asymptomatic)(12 weeks)
研究者
研究点 (1)
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