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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
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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).

Condition or disease Intervention/treatment Phase
Influenza Drug: Oseltamivir Drug: Paracetamol Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

Arm Intervention/treatment
Active Comparator: Oseltamivir
best medical care and oral oseltamivir 75 mg twice daily for five days.
Drug: Oseltamivir
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.
Drug: Paracetamol
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 :
  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. [ 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 :
  1. include time to clinical stability (defined earlier), and duration of hospitalization. [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03754686    
Other Study ID Numbers: 0520-18-RMB CTIL
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Acetaminophen
Oseltamivir
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action