A Randomized, Multicenter Trial of Oseltamivir [Tamiflu] Doses of 75 mg for 5 or 10 Days Versus 150 mg for 5 or 10 Days to Evaluate the Effect on the Duration of Viral Shedding in Influenza Patients With Pandemic (H1N1) 2009
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 102
- 主要终点
- Time to Cessation of Viral Shedding
研究概览
简要总结
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.
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, Investigator)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric, adolescent and adult patients >/=1 year of age
- •Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
- •Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
- •</=96 hours between onset of influenza-like illness and first dose of oseltamivir
排除标准
- •Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
- •History of chronic renal failure or clinical suspicion of renal failure at baseline
- •Clinical evidence of hepatic compensation at the time of randomization
- •Known HIV infection
- •Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication
研究组 & 干预措施
Oseltamivir standard dose 10 days
Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
干预措施: Placebo (Drug)
Oseltamivir high dose 5 days
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
干预措施: Oseltamivir (Drug)
Oseltamivir standard dose 5 days
Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
干预措施: Oseltamivir (Drug)
Oseltamivir standard dose 5 days
Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
干预措施: Placebo (Drug)
Oseltamivir standard dose 10 days
Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
干预措施: Oseltamivir (Drug)
Oseltamivir high dose 5 days
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
干预措施: Placebo (Drug)
Oseltamivir high dose 10 days
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
干预措施: Oseltamivir (Drug)
Oseltamivir high dose 10 days
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Cessation of Viral Shedding
时间窗: Day 1 to Day 40
The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.
次要结局
- Change From Baseline in Influenza Titer Measured by Viral Culture(Baseline, Days 2 through 15)
- Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture(Baseline and Days 3, 6, 8, 11, 15 and 40)
- Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction(Baseline and Days 3, 6, 8, 11, 15 and 40)
- Number of Participants With Development of Oseltamivir-Resistant Influenza Virus(40 days)
- Time to Resolution of Fever(Day 1 through Day 40)
- Time to Alleviation of All Clinical Symptoms - Children(Day 1 to Day 40)
- Time to Alleviation of All Clinical Symptoms - Adults(Day 1 to Day 40)
- Number of Participants Who Developed Secondary Illnesses During the Study(Day 1 through Day 40)
- Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics(Day 1 through Day 40)