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

Capital Medical University

Status: Not yet enrolling

Conditions: Influenza Prophylaxis; Nosocomial Infection; Influenza

Treatments: Drug: Baloxavir Marboxil; Drug: Oseltamivir

Study type: Interventional

Funder types: Other

Identifiers

NCT06762587

2024-KY-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 3 patient groups

Baloxavir Marboxil

Experimental group

Description:

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.

Treatment:

Drug: Baloxavir Marboxil

Oseltamivir Arm

Experimental group

Description:

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

Treatment:

Drug: Oseltamivir

Control Arm

No Intervention group

Description:

No antivirals will be administered to the contacts.