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

January 29, 2019 updated by: Rambam Health Care Campus

Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season: a Randomized Controlled Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 twice daily for five days. Dose adjustments of oseltamivir will be made according to manufacturer's instructions. Patients with creatinine clearance between 30-60 ml/minute will receive 30 mg twice daily for five days. Patients with creatinine clearance 10-30 ml/minute will receive 30 mg, once daily for 5 days. Hemodialytic patients will receive 30 mg upon admission, and 30 mg after every session, for 5 days. Patients on peritoneal dialysis will receive 30 mg once, which suffices for 5 days. Patients may withdraw participation from the trial at any time. The attending physician may also be informed the treatment arm, and start antiviral treatment if deemed necessary.

A nasopharyngeal swab for influenza will be obtained upon enrollment. PCR testing will be performed in-house. Administration of oseltamivir or paracetamol for patients with negative swabs will be stopped, unless the sample was obtained after initiation of the study drug. Patients may discontinue or refuse trial medications at any point. The reasons for discontinuation will be documented.

Adverse effects: The investigators will monitor and document daily rate of nausea, vomiting, and headache, deterioration in kidney function (defined as an increase in creatinine by >0.3 mg/dl or by >50% from baseline), and in-hospital delirium.

Participant timeline and follow-up: After signing informed consent (available in Hebrew, Arabic or Russian), study personnel, will interview patients and review electronic medical files.

Patients enrolled will be followed-up daily by study personnel in-hospital, until the first of: achieving clinical improvement (defined below), hospital discharge, or 7 days from randomization. During the follow-up patients will be assessed for clinical improvement and for AE (detailed above). Patients discharged before day 7 will be assumed to have reached clinical improvement by that time. Readmissions and deaths by day 30 will be monitored through the electronic patient file (Prometheus), providing access to a national registry of hospitalizations and updated from the national Health Ministry on deaths.

Recruitment: during the influenza high-season, ER nurses will fill in a check-box containing the SARI criteria items. An electronic report of all cases filling SARI criteria, will be sent to study personnel 5 times daily. An investigator will apply inclusion and exclusion criteria on candidates, and obtain informed consent from patients or their legal guardians. Enrollment will continue until reaching the predefined sample size.

Randomization and blinding methods: a computer-generated randomizer will be used, to assign all patients into block sizes of 8, with a 1:1 randomization rate. Allocation codes will be concealed in sealed opaque envelopes that will be opened consecutively by the randomization code. The study is open-label. Outcome assessment will be performed blinded to the treatment allocation.

Patients will be assessed once daily, by study personnel, for the clinical course of the disease and for AE. Data will be entered into a case report form (CRF). Daily assessment will end when patients are released from hospitalization, or at the end of 7 days from admission. During hospitalization, medical files will be reviewed for administration of antibiotics, respiratory deterioration (defined as new requirement of oxygen supplementation or requirement for mechanical ventilation, either invasive or non-invasive). Duration of hospitalization, as well as re-hospitalization within one month after enrollment, and 30 days mortality, available from the hospital computerized medical records, will be noted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
436

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Best medical care and oral paracetamol twice daily for five days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
include time to clinical stability (defined earlier), and duration of hospitalization.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0520-18-RMB CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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