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Clinical Trials in the USA / NCT06094010
Recruiting Phase 3

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

NCT06094010 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2023-11-22
Last updated
2026-05-01

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

Baloxavir Marboxil

Baloxavir Marboxil: Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms \[kg\]: 80 milligrams \[mg\]; ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 milligrams per kilogram \[mg/kg\]).

Study summary

This study consists of two parts: Part A Surveillance and Part B Transmission.

The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \<12 years with influenza treated with baloxavir marboxil.

Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.

Eligibility

Sex
ALL
Min age
3 Weeks
Max age
11 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Central Alabama Research Birmingham Alabama Recruiting
Harrisburg Family Medical Center Harrisburg Arkansas Recruiting
Kendall South Medical Center Inc. Miami Florida Recruiting
Avanza Medical Research Center Pensacola Florida Recruiting
Tekton Research - Chamblee Georgia Chamblee Georgia Withdrawn
Tekton Research Lawrenceville Lawrenceville Georgia Withdrawn
Velocity Clinical Research at Primary Pediatrics Macon Macon Georgia Completed
Clinical Research Prime Idaho Falls Idaho Recruiting
Mishawaka Osteopathic Clinic Mishawaka Indiana Recruiting
Kentucky Pediatric Research Center Bardstown Kentucky Recruiting
Velocity Clinical Research Lafayette Lafayette Louisiana Recruiting
Velocity Clinical Research, Slidell Slidell Louisiana Completed
Velocity Clinical Research, Grand Island Grand Island Nebraska Recruiting
Machuca Family Medicine Las Vegas Nevada Recruiting
Ohio Pediatric Research Association Dayton Ohio Recruiting
Helios Clinical Research, Inc (former Ventavia Research Group) Middleburg Heights Ohio Recruiting
Frontier Clinical Research Smithfield Pennsylvania Recruiting
Coastal Pediatric Research Charleston South Carolina Recruiting
Tekton Research - Beaumont Beaumont Texas Recruiting
Oak Cliff Research Company, LLC Dallas Texas Completed
Mercury Clinical Research Houston Texas Completed
Pioneer Research Solutions Houston Texas Recruiting
Oak Cliff Research Company, LLC Richardson Texas Recruiting
Sun Research Institute San Antonio Texas Withdrawn
Tekton Research San Antonio Texas Completed
Siena Research Network Sugar Land Texas Recruiting
Velocity Clinical Research, Salt Lake City West Jordan Utah Recruiting
Frontier Clinical Research, LLC Kingwood West Virginia Active Not Recruiting
Medical Centre "Asklepii", OOD Dupnitsa Bulgaria Completed
MHAT " St. Ivan Rilski " Kozloduy Kozloduy Bulgaria Recruiting
MHAT Stamen Iliev AD Montana Bulgaria Completed
MHAT City Clinic - Saint George Montana Bulgaria Recruiting
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd. Rousse Bulgaria Completed
MHAT Sliven - Military Medial Academy Sliven Bulgaria Recruiting
AGPSMP Pediatric diseases South park OOD Sofia Bulgaria Recruiting
Medical Center Hera Sofia Sofia Bulgaria Completed
IN VIVO Sp. z o.o. Bydgoszcz Poland Recruiting
NZOZ Vitamed Bydgoszcz Poland Recruiting
Centrum Medyczne Pratia Częstochowa Częstochowa Poland Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej "Amed" Grójec Poland Recruiting

+ 11 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06094010 on ClinicalTrials.gov ↗ ← All trials in the USA