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NCT06762587

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

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2025-01-05

Completion Date

2025-05-05

Last Updated

2025-01-07

Healthy Volunteers

Yes

Conditions

Influenza Influenza Prophylaxis Nosocomial 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.

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.

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China