Status:

UNKNOWN

Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season

Lead Sponsor:

Rambam Health Care Campus

Conditions:

Influenza

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 r...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • Age ≥18 years
  • admitted to the hospital during the influenza "high season" with SARI.

Exclusion

  • 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.
  • Pregnancy.
  • 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.

Key Trial Info

Start Date :

February 10 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2022

Estimated Enrollment :

436 Patients enrolled

Trial Details

Trial ID

NCT03754686

Start Date

February 10 2019

End Date

July 1 2022

Last Update

January 30 2019

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