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New treatment option for Influenza
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 medicine, given as a pill taken by mouth, being studied as a potential treatment for influenza.
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
- 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.
- 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
- (Part A):
- 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
- Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less (Part B): [A] IP:
- Eligible to take part in Part A
You likely can't join if
- (Part A):
- 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
See the full eligibility 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 (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...
- 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 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
- (Part A):
- 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
- Females who have commenced menarche (i.e., child-bearing potential) Exclusion Criteria (Part B):
- 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's taking place
- Birmingham, Alabama, United States
- Harrisburg, Arkansas, United States
- Miami, Florida, United States
- Pensacola, Florida, United States
- Chamblee, Georgia, United States
- Lawrenceville, Georgia, United States
- Macon, Georgia, United States
- Idaho Falls, Idaho, United States
- Mishawaka, Indiana, United States
- Bardstown, Kentucky, United States
- Lafayette, Louisiana, United States
- Slidell, Louisiana, United States
- Grand Island, Nebraska, United States
- Las Vegas, Nevada, United States
- Dayton, Ohio, United States
- Middleburg Heights, Ohio, United States
- Smithfield, Pennsylvania, United States
- Charleston, South Carolina, United States
- Beaumont, Texas, United States
- Dallas, Texas, United States
+ 25 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Birmingham, Alabama, United States; Harrisburg, Arkansas, United States; Miami, Florida, United States; Pensacola, Florida, United States; Chamblee, Georgia, United States; Lawrenceville, Georgia, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.