Influenza study: Baloxavir Marboxil
Official title A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
ClinicalTrials.gov ID: NCT06094010
What this study is testing
What is Baloxavir Marboxil?
Baloxavir marboxil is an investigational oral medicine being studied as a potential treatment for influenza. It is designed to inhibit the influenza virus cap‑dependent endonuclease, blocking viral replication.
Also referred to as XOFLUZA®, RO7191686.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if the flu virus changes in children taking baloxavir and whether the drug prevents the flu from spreading to people living in the same home.
- Who it's for
- The study is looking for children under 12 years old who have the flu and are taking the medication baloxavir.
- What's involved
- Participants will take the flu medication and provide samples to check for changes in the virus. Some children under 12 will also have their household members join to track if the flu spreads to them.
- Time commitment
- The study involves monitoring the child and their household contacts for a period to track the virus and any new cases of flu.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 11
You may be able to join if
- Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test...
- Participants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screening
- Eligible to take part in Part A
- 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
You likely can't join if
- Participants with severe influenza virus infection requiring inpatient treatment
- Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency...
- 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...
- 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
See the full eligibility criteria
- 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
- Eligible to take part in Part A
- 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.
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Harrisburg, Arkansas, United States
- Miami, Florida, United States
- Idaho Falls, Idaho, United States
- Mishawaka, Indiana, United States
- Bardstown, Kentucky, United States
- Lafayette, Louisiana, United States
- Middleburg Heights, Ohio, United States
- Smithfield, Pennsylvania, United States
- Houston, Texas, United States
- Sugar Land, Texas, United States
- Sofia, Bulgaria
- Bydgoszcz, Poland
- Częstochowa, Poland
- Grójec, Poland
- Katowice, Poland
- Siemianowice Śląskie, Poland
- Wroclaw, Poland
- Łęczna, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 weeks to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Harrisburg, Arkansas, United States; Miami, Florida, United States; Idaho Falls, Idaho, United States; Mishawaka, Indiana, United States; Bardstown, Kentucky, United States and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.