Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 436
- 主要终点
- the composite of failure to reach clinical stability at day 7 after randomization OR transfer to the ICU until day 7 after randomization OR re-admission within 30 days of randomization OR death within 30 days of randomization.
研究概览
简要总结
Parallel group, investigator initiated, 1:1, open-label, non-inferiority randomized controlled trial, aiming to show that paracetamol is non-inferior to oseltamivir among patients with serious acute respiratory infection (SARI).
详细描述
Study setting: a single tertiary hospital, containing 1,000 beds. Intervention: best medical care and oral oseltamivir 75 mg twice daily for five days.
Control: best medical care and oral paracetamol twice daily for five days. Dose adjustments of oseltamivir will be made according to manufacturer's instructions. Patients with creatinine clearance between 30-60 ml/minute will receive 30 mg twice daily for five days. Patients with creatinine clearance 10-30 ml/minute will receive 30 mg, once daily for 5 days. Hemodialytic patients will receive 30 mg upon admission, and 30 mg after every session, for 5 days. Patients on peritoneal dialysis will receive 30 mg once, which suffices for 5 days. Patients may withdraw participation from the trial at any time. The attending physician may also be informed the treatment arm, and start antiviral treatment if deemed necessary.
A nasopharyngeal swab for influenza will be obtained upon enrollment. PCR testing will be performed in-house. Administration of oseltamivir or paracetamol for patients with negative swabs will be stopped, unless the sample was obtained after initiation of the study drug. Patients may discontinue or refuse trial medications at any point. The reasons for discontinuation will be documented.
Adverse effects: The investigators will monitor and document daily rate of nausea, vomiting, and headache, deterioration in kidney function (defined as an increase in creatinine by >0.3 mg/dl or by >50% from baseline), and in-hospital delirium.
Participant timeline and follow-up: After signing informed consent (available in Hebrew, Arabic or Russian), study personnel, will interview patients and review electronic medical files.
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
- None
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
- •Age ≥18 years
- •admitted to the hospital during the influenza "high season" with SARI.
排除标准
- •Severe disease on admission, defined as any of the following: patients deemed to require intensive care immediately upon admission, a high probability of imminent respiratory failure as judged by the ER physician.
- •Severe immunosuppression including: Acquired immunodeficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) with unknown CD4 or with CD4 < 200/mL, solid organ and stem cell transplant recipients, or neutrophil count of less than 100 per µliter.
- •Patients with decompensated cirrhosis.
- •Patients discharged home from the ER.
- •Patients unable to sign informed consent with no legal guardian.
- •Patients who received at least 2 doses of oseltamivir prior to randomization.
研究组 & 干预措施
Oseltamivir
best medical care and oral oseltamivir 75 mg twice daily for five days.
干预措施: Oseltamivir (Drug)
Paracetamol
best medical care and oral paracetamol twice daily for five days.
干预措施: Paracetamol (Drug)
结局指标
主要结局
the composite of failure to reach clinical stability at day 7 after randomization OR transfer to the ICU until day 7 after randomization OR re-admission within 30 days of randomization OR death within 30 days of randomization.
时间窗: 30 days
Clinical stability will be defined as: heart rate \< 100/min AND systolic blood pressure \> 90 mmHG AND temperature ≤ 38.00 AND respiratory rate ≤ 24 AND oxygen saturation ≥ 90.
次要结局
- include time to clinical stability (defined earlier), and duration of hospitalization.(30 days)