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

ConditionsInfluenzaInfluenza ProphylaxisNosocomial Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baloxavir Marboxil

    Drug

    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.

  • Oseltamivir

    Drug

    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 groups

372 Participants
are divided into 3 treatment groups
Group A: Baloxavir MarboxilExperimental treatment 1 intervention
Group B: Oseltamivir ArmExperimental treatment 1 intervention
Group C: Control ArmNo intervention 0 interventions

Trial outcomes

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.

Time frame
up to 5 days

Secondary outcomes

1

Incidence of influenza within a 5-day period

Incidence of 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).

Time frame
up to 5 days
2

Incidence of Clinical Influenza within a 10-day period

Incidence of Clinical Influenza within a 10-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.

Time frame
up to 10 days
3

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

Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation is defined as the percentage of contacts infected with resistance-associated treatment-emergent influenza variants.

Time frame
up to 10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

China-Japan Friendship Hospital

Collaborator

Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: