A Randomized, Double-Blinded Controlled Trial Comparing High vs Standard Dose Oseltamivir in Severe, Influenza Infection in ICU. "ROSII Study"
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Negative reverse transcriptase (RT)-PCR detection of viral RNA in nasopharyngeal and tracheal aspirate (intubated) or oropharyngeal (non-intubated) samples at Day 5 among patients who require ICU admission due to respiratory distress.
研究概览
简要总结
Primary Objectives:
The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections.
The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment.
An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups
详细描述
Primary Objectives:
The primary objective of the trial is to compare the antiviral efficacy of a 10 day course of standard (75 mg bid) and high-dose (225 mg bid) oseltamivir (or equivalent doses in mild-moderate renal failure) in the treatment of severe influenza infections.
The hypothesis is that high dose oseltamivir will increase the proportion of patients with negative reverse transcriptase (RT)-PCR detection of influenza viral RNA (and viral culture, at selected sites) at Day 5 post-treatment.
An important secondary objective of the trial, which reflects the main clinical objective, is to determine the difference in the numbers of ventilator days between the standard-dose and high-dose groups.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 12 and older and 45 kg or more
- •Suspected or confirmed influenza (Appendix A)
- •Requirement for ICU admission due to respiratory distress or critical illness defined as one of:
- •Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B)
- •mechanical ventilation
- •Patient is receiving inotrope or vasopressor
- •Negative b-HCG test or negative bedside urine test pending a confirmatory b-HCG test for pregnancy in women of childbearing age (12-60 years of age) will allow study entry
排除标准
- •Inability to obtain consent
- •Patients receiving more than two doses of 150 mg or higher oseltamivir in 36 hours before study entry
- •Patients having received more than 3 doses of 75 mg oseltamivir immediately in 36 hours before study entry
- •Age less than 12 years, or age <16 and weight less than 45 kg
- •Unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome)
- •Known allergy or hypersensitivity to oseltamivir
- •Pregnancy or breast feeding
- •Previous enrollment in current study
- •Concurrent involvement in an RCT examining an antiviral agent including other neuraminidase inhibitors, interferon-a and/or ribavirin
- •Chronic renal failure requiring chronic hemodialysis
- •Severe chronic liver disease (Child-Pugh Score 11-15)
- •Anticipated death within 24 hours as judged by attending physician or local PI
- •Patient carrying "do not intubate" order (a "no CPR" or "no defibrillate" or "no chest compressions" order alone is allowed)
研究组 & 干预措施
Standard Oseltamivir dose 75 mg bid
Standard dosing
干预措施: Oseltamivir (Drug)
High Dose Oseltamivir arm 225mg bid
High dose arm of the study
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Negative reverse transcriptase (RT)-PCR detection of viral RNA in nasopharyngeal and tracheal aspirate (intubated) or oropharyngeal (non-intubated) samples at Day 5 among patients who require ICU admission due to respiratory distress.
时间窗: Day 5 on study
次要结局
- Ventilator days up to 60 d (main clinical endpoint),(60 days)