Surveillance Study of Baloxavir Marboxil in Children with Influenza
This study is looking at how well the antiviral medicine Baloxavir Marboxil works in children under 12 years old who have the flu. Researchers want to see if the flu virus develops resistance to the medicine, meaning the medicine might not work as well. They will check for changes in the virus before treatment and at different times after treatment. The study is for children aged 3 weeks to 11 years who have flu symptoms and a confirmed flu diagnosis. You would need to have a negative test for COVID-19 before joining. The study aims to understand how the flu virus responds to Baloxavir Marboxil in young patients.
- Study design
- This is an interventional study with a planned enrollment of 1100 participants. It focuses on observing how the flu virus changes in response to treatment with Baloxavir Marboxil.
- What's involved
- Participants will receive Baloxavir Marboxil as an oral suspension. Samples will be collected on Day 1 (before treatment) and on Days 4, 6, and 10 to check for changes in the flu virus.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in the flu virus up to Day 10 after starting treatment.
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NCT06094010
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Recruiting
PHASE3Ages 3–11InterventionalTreatmentHoffmann-La Roche
~1,100 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Baloxavir Marboxil
At a glance
Recruiting sites
32 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
Measured over Day 1 (At Baseline)
+1 more outcome measured
Conditions
Where it's being run
51 sites across 20 statesPoland11
Texas8
Bulgaria8
Georgia3
Spain3
Florida2
Louisiana2
Ohio2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
Reference Study ID Number: CV44536 https://forpatients.roche.com/
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Eligibility criteria
Inclusion
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
Eligible to take part in Part A
Lives in a household with a HHC willing to be recruited as full 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
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
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)
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
What this trial measures
- Part A: Percentage of Participants With Resistance-associated Pre-treatment SubstitutionsDay 1 (At Baseline)
- Part A: Percentage of Participants With Resistance-associated Treatment-emergent SubstitutionsDays 4, 6 and 10