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

NCT03754686 | Unknown Phase 4

• 1 other identifier: 0520-18-RMB CTIL
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

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 respiratory infection (SARI).

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  30 days

Secondary Outcomes (1)

• include time to clinical stability (defined earlier), and duration of hospitalization.

  30 days

Study Arms (2)

Oseltamivir

ACTIVE COMPARATOR

best medical care and oral oseltamivir 75 mg twice daily for five days.

Drug: Oseltamivir

Paracetamol

ACTIVE COMPARATOR

best medical care and oral paracetamol twice daily for five days.

Drug: Paracetamol

Interventions

Oseltamivir DRUG

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.

Oseltamivir

Paracetamol DRUG

Best medical care and oral paracetamol twice daily for five days

Also known as: Best medical care and oral paracetamol twice daily for five days.

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 27, 2018
• Study Start: February 10, 2019
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 30, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share