Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Time to symptoms resolution as reported by the patient
研究概览
简要总结
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
详细描述
The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.
The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female patients 18 years or older with body weight >40kg
- •Written informed consent
- •Presented within 48 hours of onset of influenza-like illness
- •Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
- •Clinical criteria
- •Fever >38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
- •At least one upper respiratory tract infection (cough, running nose, sore throat)
- •Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms
排除标准
- •Age below 18 years
- •Persons who lack the ability to care for themselves
- •Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- •Pregnancy or lactation
- •Coexisting liver disease
- •Coexisting cardiovascular disease except stable hypertension without complication
- •Coexisting chronic pulmonary disease
- •Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
- •Renal failure
- •Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
- •Known intolerance to oseltamivir or zanamivir
- •Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
- •Subjects who have received oseltamivir as prophylaxis for H1N1 infection
- •Subjects who have received any investigational drug within 1 month prior to study entry
- •Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
研究组 & 干预措施
Oseltamivir
干预措施: Oseltamivir (Drug)
Zanamivir
干预措施: Zanamivir (Drug)
Placebo of Oseltamivir
干预措施: Placebo of Oseltamivir (Drug)
结局指标
主要结局
Time to symptoms resolution as reported by the patient
时间窗: one week
次要结局
- Treatment failure including hospitalization due to disease worsening.(one week)
- Viral load(one week)
- Severity of disease as measured by the patient diary and quality of life using SF12v2.(one week)