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

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two antiviral medications, baloxavir marboxil and oseltamivir, to see if they can help prevent influenza in people who are close contacts of patients already hospitalized with the virus. The goal is to find out if taking one of these medications can reduce the chances of developing influenza for those who have been around infected patients in a hospital setting. Participants will be randomly assigned to receive either one of the medications or no treatment at all, and researchers will monitor how many develop influenza while participating in the study.

To be eligible for this trial, participants must be at least 2 years old and either hospitalized patients with confirmed influenza or caregivers staying close to them. Caregivers need to agree to participate and must have tested negative for the virus on the first day. It’s important to note that people with certain health conditions, recent illnesses, or allergies to the medications will not be able to participate. If you join the study, you will be closely monitored, and the information gathered will help improve the prevention of influenza in hospital settings.

Gender

ALL

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.