Actively Recruiting
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Led by Hoffmann-La Roche · Updated on 2026-05-01
1100
Participants Needed
51
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Participants with symptoms suggestive of influenza confirmed by a positive influenza test within 24 hours before screening
- Participants with a negative SARS-CoV-2 test within 48 hours before screening
- Onset of influenza symptoms within 48 hours before starting pre-dose examinations
- For Part B, index participants must be eligible for Part A and live with household contacts willing to participate
- Household contacts must meet specific screening criteria depending on partial or full-study participation
- Full-study household contacts must reside in the participant's home for at least 12 of the next 15 days and have no influenza symptoms within 7 days prior to screening
- Household contacts must not have moderate or worse active infections requiring systemic antibiotic, antiviral, or antifungal therapy
You will not qualify if you...
- Participants with severe influenza requiring inpatient treatment
- Severely immunocompromised participants as defined by the investigator
- Participants with other infections needing systemic antimicrobial or antiviral therapy at pre-dose exams
- Treatment with baloxavir marboxil or other listed influenza antivirals within 30 days prior to screening
- Treatment with investigational influenza monoclonal antibody within 6 months or 5 half-lives prior to screening
- Treatment with any investigational therapy within 30 days or 5 half-lives prior to screening
- Known allergy to baloxavir marboxil or its ingredients
- Females who have started menstruation (child-bearing potential)
- Household contacts requiring influenza post-exposure prophylaxis
- Household contacts diagnosed with influenza by a healthcare professional in the past 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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/
CONTACT
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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