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Not yet recruiting NCT06762587

Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

No phase Interventional Influenza Influenza Prophylaxis Nosocomial Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baloxavir Marboxil, Oseltamivir.
Who it may be relevant to
Registry conditions: Influenza, Influenza Prophylaxis, Nosocomial Infection. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting

Overview

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

Detailed description

This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.

Interventions

  • Drug Baloxavir Marboxil
    Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg.
  • Drug Oseltamivir
    Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day.

Primary outcome measures

  • Incidence of Clinical Influenza within a 5-day period [Time frame: up to 5 days]
Secondary outcome measures (3)
  • Incidence of influenza within a 5-day period [Time frame: up to 5 days]
  • Incidence of Clinical Influenza within a 10-day period [Time frame: up to 10 days]
  • Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation [Time frame: up to 10 days]

Eligibility criteria

Inclusion criteria

  • Index patient:
  • 1\. Patients or accompanying caregivers hospitalized at participating medical institutions.
  • 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
  • 3.Age ≥ 2 years.
  • 4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
  • Close contact:
  • 1.Patients or accompanying caregivers hospitalized at participating medical institutions.
  • 2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and complete all study procedures and assessments
  • 3.Age ≥ 12 years.
  • 4.Expected to remain hospitalized for ≥ 72 hours.
  • 5.The room must contain at least one hospitalized index patient diagnosed with influenza virus within the past 72 hours, and the contact is expected to stay with the hospitalized index patient in the ward for more than 24 hours.
  • 6.Throat swab on the first day tested negative for influenza virus by PCR.

Exclusion criteria

  • Close contacts
  • 1.With known allergies to the active ingredients or excipients of the investigational drug.
  • 2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
  • 3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
  • 4.Close contacts known to be pregnant or breastfeeding.
  • 5\. Having experienced fever (axillary temperature ≥37.3°C) in the past 3 days prior to screening.
  • 6.Subjects deemed unsuitable to participate in the study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT06762587 · 2024-KY-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗