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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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 respiratory infection (SARI).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Acetaminophen; Oseltamivir

Criteria

Inclusion Criteria:

• Age ≥18 years

• admitted to the hospital during the influenza "high season" with SARI.

Exclusion Criteria:

1. 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.

2. Pregnancy.

3. 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.

4. Patients with decompensated cirrhosis.

5. Patients discharged home from the ER.

6. Patients unable to sign informed consent with no legal guardian.

7. Patients who received at least 2 doses of oseltamivir prior to randomization.