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New flu drug under watch in kids: will it work and stop family spread?

NCT ID NCT06094010

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the flu drug baloxavir marboxil works in children under 12 and whether it stops the flu from spreading to family members. About 1,100 kids with flu symptoms will take the drug, and researchers will check for drug resistance and track infections in household contacts. The goal is to understand the drug's effectiveness and safety in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 weeks to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Part A): * Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening * Participants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screening * Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less Inclusion Criteria (Part B): \[A\] IP: * Eligible to take part in Part A * Lives in a household with a HHC willing to be recruited as full HHC \[B\] HHCs: \- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility \[C\] Partial HHC: * Starts screening within 1 calendar day after IP treatment * Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil * HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening * HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements, and at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening. * HHC lives with other HHCs (if applicable) who fulfill all the "partial HHC" criteria \[D\] Full-study HHC: * Fulfills the "partial HHC" criteria * Agrees to participate in the full study * Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits * No influenza symptoms within 7 days prior to screening * Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic/antiviral/antifungal therapy Exclusion Criteria (Part A): * Participants with severe influenza virus infection requiring inpatient treatment * Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus \[HIV\] infection) as defined by the investigator * Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations * Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening * Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening * Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening * Known hypersensitivity to baloxavir marboxil or the drug product excipients * Females who have commenced menarche (i.e., child-bearing potential) Exclusion Criteria (Part B): * IPs who fulfil an exclusion criterion for Part A * HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice * HHCs diagnosed with influenza by health care professional in the past 4 weeks

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Conditions

The condition(s) this trial relates to.

influenza

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AGPSMP Pediatric diseases South park OOD

    RECRUITING

    Sofia, 1421, Bulgaria

  • Avanza Medical Research Center

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Central Alabama Research

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Centrum Medyczne K2J2

    COMPLETED

    Lodz, 92-108, Poland

  • Centrum Medyczne K2J2

    WITHDRAWN

    Wo?omin, 05-200, Poland

  • Centrum Medyczne Pratia Częstochowa

    RECRUITING

    Częstochowa, 42-200, Poland

  • Clinical Research Prime

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • Coastal Pediatric Research

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    WITHDRAWN

    Santiago de Compostela, LA Coruna, 15706, Spain

  • Frontier Clinical Research

    RECRUITING

    Smithfield, Pennsylvania, 15478, United States

  • Frontier Clinical Research, LLC

    ACTIVE_NOT_RECRUITING

    Kingwood, West Virginia, 26537, United States

  • Harrisburg Family Medical Center

    RECRUITING

    Harrisburg, Arkansas, 72432, United States

  • Helios Clinical Research, Inc (former Ventavia Research Group)

    RECRUITING

    Middleburg Heights, Ohio, 44130-3643, United States

  • Hospital Infantil Universitario Nino Jesus

    WITHDRAWN

    Madrid, 28009, Spain

  • Hospital Universitari i Politècnic La Fe

    COMPLETED

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    WITHDRAWN

    Madrid, 28041, Spain

  • IN VIVO Sp. z o.o.

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • Jaroslaw Kierkus Prywatna Prakyka Lekarska

    RECRUITING

    Warsaw, 04-501, Poland

  • Kendall South Medical Center Inc.

    RECRUITING

    Miami, Florida, 33185, United States

  • Kentucky Pediatric Research Center

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • MHAT " St. Ivan Rilski " Kozloduy

    RECRUITING

    Kozloduy, 3320, Bulgaria

  • MHAT City Clinic - Saint George

    RECRUITING

    Montana, 3403, Bulgaria

  • MHAT Sliven - Military Medial Academy

    RECRUITING

    Sliven, 8800, Bulgaria

  • MHAT Stamen Iliev AD

    COMPLETED

    Montana, 3400, Bulgaria

  • Machuca Family Medicine

    RECRUITING

    Las Vegas, Nevada, 89104, United States

  • Medical Center Hera Sofia

    COMPLETED

    Sofia, 1510, Bulgaria

  • Medical Centre "Asklepii", OOD

    COMPLETED

    Dupnitsa, 2600, Bulgaria

  • Mercury Clinical Research

    COMPLETED

    Houston, Texas, 77087, United States

  • Mishawaka Osteopathic Clinic

    RECRUITING

    Mishawaka, Indiana, 46544, United States

  • NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska

    RECRUITING

    Siemianowice Śląskie, 41-103, Poland

  • NZOZ Salmed

    RECRUITING

    Łęczna, 21-010, Poland

  • NZOZ Vitamed

    RECRUITING

    Bydgoszcz, 85-079, Poland

  • Niepubliczny Zaklad Opieki Zdrowotnej "Amed"

    RECRUITING

    Grójec, 05-600, Poland

  • Oak Cliff Research Company, LLC

    COMPLETED

    Dallas, Texas, 75287, United States

  • Oak Cliff Research Company, LLC

    RECRUITING

    Richardson, Texas, 75287, United States

  • Ohio Pediatric Research Association

    RECRUITING

    Dayton, Ohio, 45414, United States

  • Pioneer Research Solutions

    RECRUITING

    Houston, Texas, 77099, United States

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    COMPLETED

    Rousse, 7002, Bulgaria

  • Siena Research Network

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Sun Research Institute

    WITHDRAWN

    San Antonio, Texas, 78215, United States

  • Tekton Research

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Tekton Research - Beaumont

    RECRUITING

    Beaumont, Texas, 77706, United States

  • Tekton Research - Chamblee Georgia

    WITHDRAWN

    Chamblee, Georgia, 30341, United States

  • Tekton Research Lawrenceville

    WITHDRAWN

    Lawrenceville, Georgia, 30043, United States

  • Velocity Clinical Research Lafayette

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research at Primary Pediatrics Macon

    COMPLETED

    Macon, Georgia, 31210, United States

  • Velocity Clinical Research, Grand Island

    RECRUITING

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research, Salt Lake City

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Slidell

    COMPLETED

    Slidell, Louisiana, 31210, United States

  • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

    RECRUITING

    Wroclaw, 53-149, Poland

  • Vita Longa Sp. z o.o.

    RECRUITING

    Katowice, 40-748, Poland

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Other studies related to the condition(s) this trial covers.