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

Sponsor
Capital Medical University
Study ID
NCT06762587
Status
Not Yet Recruiting

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Conditions

  • Influenza
  • Influenza Prophylaxis
  • Nosocomial Infection

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Baloxavir Marboxil — DRUG
    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.
  • Oseltamivir — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 7, 2025
Start date
Jan 5, 2025
Status verified
Jan 2025
Primary completion
Apr 30, 2025
Completion
May 5, 2025

Study Design

Enrollment
372 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Experimental: Oseltamivir Arm
    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
  • No Intervention: Control Arm
    No antivirals will be administered to the contacts.

Primary Outcome Measure

Incidence of Clinical Influenza within a 5-day period [ Time Frame: up to 5 days ]

Central Contacts

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