Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03754686|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : January 30, 2019
Rambam Health Care Campus
Information provided by (Responsible Party):
Rambam Health Care Campus
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).
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: Oseltamivir Drug: Paracetamol||Phase 4|
Show detailed description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season: a Randomized Controlled Trial|
|Estimated Study Start Date :||February 10, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Active Comparator: Oseltamivir
best medical care and oral oseltamivir 75 mg twice daily for five days.
Best medical care and oral oseltamivir 75 mg twice daily for five days. Dose adjustments of oseltamivir will be made according to manufacturer's instructions.
Active Comparator: Paracetamol
best medical care and oral paracetamol twice daily for five days.
Best medical care and oral paracetamol twice daily for five days
Other Name: Best medical care and oral paracetamol twice daily for five days.
Primary Outcome Measures :
- 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. [ Time Frame: 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.
Secondary Outcome Measures :
- include time to clinical stability (defined earlier), and duration of hospitalization. [ Time Frame: 30 days ]
No Contacts or Locations Provided