A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
NCT ID: NCT06094010
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
750 participants
INTERVENTIONAL
2023-11-22
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' susceptibility \<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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
NCT03629184
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
NCT03653364
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
NCT06774859
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
NCT03684044
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
NCT06507813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment.
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 mg/kg).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 mg/kg).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 pre-dose examinations at screening is 48 hours or less
\[A\] IP:
* Eligible to take part in Part A
* Lives in a household with a HHC willing to be recruited as full household contact
\[B\] 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 household contact" criteria
\[D\] Full-study HHC:
* Fulfills the "Partial household contact" 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
* 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 fulfill 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
3 Weeks
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Alabama Research
Birmingham, Alabama, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Kendall South Medical Center Inc.
Miami, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Tekton Research - Chamblee Georgia
Chamblee, Georgia, United States
Tekton Research Lawrenceville
Lawrenceville, Georgia, United States
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Mishawaka Osteopathic Clinic
Mishawaka, Indiana, United States
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States
Velocity Clinical Research Lafayette
Lafayette, Louisiana, United States
Velocity Clinical Research, Slidell
Slidell, Louisiana, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Machuca Family Medicine
Las Vegas, Nevada, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights, Ohio, United States
Frontier Clinical Research
Smithfield, Pennsylvania, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Tekton Research - Beaumont
Beaumont, Texas, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
Mercury Clinical Research
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Oak Cliff Research Company, LLC
Richardson, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Tekton Research
San Antonio, Texas, United States
Siena Research Network
Sugar Land, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, United States
Medical Centre "Asklepii", OOD
Dupnitsa, , Bulgaria
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy, , Bulgaria
MHAT Stamen Iliev AD
Montana, , Bulgaria
MHAT City Clinic - Saint George
Montana, , Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, , Bulgaria
MHAT Sliven - Military Medial Academy
Sliven, , Bulgaria
AGPSMP Pediatric diseases South park OOD
Sofia, , Bulgaria
Medical Center Hera Sofia
Sofia, , Bulgaria
NZOZ Salmed
??czna, , Poland
Centrum Medyczne K2J2
?ód?, , Poland
IN VIVO Sp. z o.o.
Bydgoszcz, , Poland
NZOZ Vitamed
Bydgoszcz, , Poland
Centrum Medyczne Pratia Cz?stochowa
Cz?stochowa, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grójec, , Poland
Vita Longa Sp. z o.o.
Katowice, , Poland
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
Siemianowice ?l?skie, , Poland
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warsaw, , Poland
Centrum Medyczne K2J2
Wo?omin, , Poland
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroc?aw, , Poland
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: CV44536 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-504672-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
CV44536
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.