Actively Recruiting
A Phase IIIb Open-label Study of Baloxavir Marboxil in Children With Influenza and Transmission to Household Contacts
Led by Hoffmann-La Roche · Updated on 2026-05-01
1100
Participants Needed
51
Research Sites
7 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying influenza in children younger than 12 years to understand how the virus changes when treated with the drug baloxavir marboxil. This study has two parts: Part A monitors the presence and development of specific changes in the virus before and after treatment in pediatric patients. Part B focuses on how influenza spreads within households from treated children under 12 to their family members, though no new participants will join Part B as per the latest study update. Participants receive a single oral dose of baloxavir marboxil on the first day, with the dose based on their body weight and age. Household contacts of the treated children are enrolled for observation but do not receive the drug. The study tracks viral changes and resistance at multiple points, including baseline and several days after treatment, and monitors influenza transmission within households. Throughout the study, children will undergo various tests such as local influenza and SARS-CoV-2 testing to confirm infection status. Researchers will measure how often virus mutations associated with resistance occur, changes in viral levels, and any side effects up to 29 days. For household contacts, influenza transmission and symptom development are checked on days 6 and 10. Participation involves scheduled visits and testing to gather this information, with the study expected to continue until mid-2027.
CONDITIONS
Brief Title
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 weeks to under 12 years with flu symptoms confirmed by a positive local influenza test within 24 hours before screening
- Negative SARS-CoV-2 test within 48 hours before screening
- Flu symptoms started 48 hours or less before screening
- For Part B, child must be in Part A and live with household contacts willing to participate
- Household contacts must meet specific criteria including negative flu and SARS-CoV-2 tests and no recent flu symptoms
- Household contacts must reside in the child's home for most of the study period and agree to full participation
You will not qualify if you...
- Children with severe influenza requiring hospital treatment
- Severely immunocompromised children or those with infections needing systemic anti-microbial or antiviral therapy
- Prior treatment with baloxavir marboxil or other specific flu medications within 30 days
- Prior treatment with investigational influenza monoclonal antibodies within 6 months
- Known allergy to baloxavir marboxil or its ingredients
- Females who have started menstruation (child-bearing potential)
- Household contacts requiring flu antiviral prophylaxis due to risk
- Household contacts diagnosed with flu in the past 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 1 day
Participants receive a single oral dose of baloxavir marboxil based on body weight and age.
1 treatment visit (in-person) on Day 1
Duration - Up to 29 days
Participants are monitored for treatment effects, resistance-associated substitutions, viral titers, and adverse events.
Visits on Days 4, 6, 10, and up to Day 29 for safety monitoring
Trial Site Locations
Total: 51 locations
1
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States, 72432
Actively Recruiting
3
Kendall South Medical Center Inc.
Miami, Florida, United States, 33185
Actively Recruiting
4
Avanza Medical Research Center
Pensacola, Florida, United States, 32503
Actively Recruiting
5
Tekton Research - Chamblee Georgia
Chamblee, Georgia, United States, 30341
Withdrawn
6
Tekton Research Lawrenceville
Lawrenceville, Georgia, United States, 30043
Withdrawn
7
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia, United States, 31210
Completed
8
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
9
Mishawaka Osteopathic Clinic
Mishawaka, Indiana, United States, 46544
Actively Recruiting
10
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States, 40004
Actively Recruiting
11
Velocity Clinical Research Lafayette
Lafayette, Louisiana, United States, 70508
Actively Recruiting
12
Velocity Clinical Research, Slidell
Slidell, Louisiana, United States, 31210
Completed
13
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
14
Machuca Family Medicine
Las Vegas, Nevada, United States, 89104
Actively Recruiting
15
Ohio Pediatric Research Association
Dayton, Ohio, United States, 45414
Actively Recruiting
16
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights, Ohio, United States, 44130-3643
Actively Recruiting
17
Frontier Clinical Research
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
18
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
Actively Recruiting
19
Tekton Research - Beaumont
Beaumont, Texas, United States, 77706
Actively Recruiting
20
Oak Cliff Research Company, LLC
Dallas, Texas, United States, 75287
Completed
21
Mercury Clinical Research
Houston, Texas, United States, 77087
Completed
22
Pioneer Research Solutions
Houston, Texas, United States, 77099
Actively Recruiting
23
Oak Cliff Research Company, LLC
Richardson, Texas, United States, 75287
Actively Recruiting
24
Sun Research Institute
San Antonio, Texas, United States, 78215
Withdrawn
25
Tekton Research
San Antonio, Texas, United States, 78229
Completed
26
Siena Research Network
Sugar Land, Texas, United States, 77479
Actively Recruiting
27
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
Actively Recruiting
28
Frontier Clinical Research, LLC
Kingwood, West Virginia, United States, 26537
Active, Not Recruiting
29
Medical Centre "Asklepii", OOD
Dupnitsa, Bulgaria, 2600
Completed
30
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy, Bulgaria, 3320
Actively Recruiting
31
MHAT Stamen Iliev AD
Montana, Bulgaria, 3400
Completed
32
MHAT City Clinic - Saint George
Montana, Bulgaria, 3403
Actively Recruiting
33
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, Bulgaria, 7002
Completed
34
MHAT Sliven - Military Medial Academy
Sliven, Bulgaria, 8800
Actively Recruiting
35
AGPSMP Pediatric diseases South park OOD
Sofia, Bulgaria, 1421
Actively Recruiting
36
Medical Center Hera Sofia
Sofia, Bulgaria, 1510
Completed
37
IN VIVO Sp. z o.o.
Bydgoszcz, Poland, 85-048
Actively Recruiting
38
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
Actively Recruiting
39
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland, 42-200
Actively Recruiting
40
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grójec, Poland, 05-600
Actively Recruiting
41
Vita Longa Sp. z o.o.
Katowice, Poland, 40-748
Actively Recruiting
42
Centrum Medyczne K2J2
Lodz, Poland, 92-108
Completed
43
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
Siemianowice Śląskie, Poland, 41-103
Actively Recruiting
44
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warsaw, Poland, 04-501
Actively Recruiting
45
Centrum Medyczne K2J2
Wo?omin, Poland, 05-200
Withdrawn
46
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroclaw, Poland, 53-149
Actively Recruiting
47
NZOZ Salmed
Łęczna, Poland, 21-010
Actively Recruiting
48
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain, 15706
Withdrawn
49
Hospital Infantil Universitario Nino Jesus
Madrid, Spain, 28009
Withdrawn
50
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Withdrawn
51
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Completed
Research Team
R
Reference Study ID Number: CV44536 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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