NCT06762587

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 30, 2024

Last Update Submit

January 6, 2025

Conditions

InfluenzaInfluenza ProphylaxisNosocomial Infection

Keywords

influenzainfluenza prophylaxisbaloxavir marboxiloseltamivirnosocomial infection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Clinical Influenza within a 5-day period

    Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.

    up to 5 days

Secondary Outcomes (3)

  • Incidence of influenza within a 5-day period

    up to 5 days

  • Incidence of Clinical Influenza within a 10-day period

    up to 10 days

  • Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation

    up to 10 days

Study Arms (3)

Baloxavir Marboxil

EXPERIMENTAL

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: Baloxavir Marboxil

Oseltamivir Arm

EXPERIMENTAL

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

Drug: Oseltamivir

Control Arm

NO INTERVENTION

No antivirals will be administered to the contacts.

Interventions

Baloxavir MarboxilDRUG

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.

Baloxavir Marboxil
OseltamivirDRUG

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.

Oseltamivir Arm

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Index patient:
  • \. Patients or accompanying caregivers hospitalized at participating medical institutions.
  • 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.
  • Age ≥ 2 years.
  • Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
  • Close contact:
  • Patients or accompanying caregivers hospitalized at participating medical institutions.
  • 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
  • Age ≥ 12 years.
  • Expected to remain hospitalized for ≥ 72 hours.
  • 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.
  • Throat swab on the first day tested negative for influenza virus by PCR.

You may not qualify if:

  • Close contacts
  • With known allergies to the active ingredients or excipients of the investigational drug.
  • Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
  • 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.
  • Close contacts known to be pregnant or breastfeeding.
  • \. Having experienced fever (axillary temperature ≥37.3°C) in the past 3 days prior to screening.
  • Subjects deemed unsuitable to participate in the study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Influenza, HumanCross Infection

Interventions

baloxavirOseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Bin Cao, Ph.D

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeming Wang, Ph.D.

CONTACT

+86 84206264wwyymm_love@163.com

Ziyi Chu

CONTACT

+86 18168859689ziyichu123@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 7, 2025

Study Start

January 5, 2025

Primary Completion

April 30, 2025

Study Completion

May 5, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)