Clinical trial NCT06762587: Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Influenza
Influenza Prophylaxis
Nosocomial Infection
Keywords: influenza
influenza prophylaxis
baloxavir marboxil
oseltamivir
nosocomial infection
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Chinese Academy of Medical Sciences
First posted: 2025-01-07
Enrollment: 372
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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.

Primary outcomes:
measure: Incidence of Clinical Influenza within a 5-day period
timeFrame: up to 5 days
Secondary outcomes:
measure: Incidence of influenza within a 5-day period
timeFrame: up to 5 days
measure: Incidence of Clinical Influenza within a 10-day period
timeFrame: up to 10 days
measure: Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: