A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influ… (NCT06094010) | Clinical Trial Compass
RecruitingPhase 3
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
United States, Bulgaria, Poland1,100 participantsStarted 2023-11-22
Plain-language 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.
Who can participate
Age range
3 Weeks – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 partic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
Timeframe: Day 1 (At Baseline)
2
Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions
Timeframe: Days 4, 6 and 10
Trial details
NCT IDNCT06094010
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-05-11
Contact for this trial
Reference Study ID Number: CV44536 https://forpatients.roche.com/