A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Launched by HOFFMANN-LA ROCHE · Oct 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called baloxavir marboxil to see how effective it is in treating influenza in children aged 1 to under 12 years old. The researchers want to determine how well the medication works before and after a single dose is given to participants who have been diagnosed with influenza. The trial is currently looking for participants who have symptoms of the flu and have tested positive for it within the last 24 hours.

To qualify for the study, children must also have tested negative for COVID-19 within the past two days and need to have had flu symptoms for less than two days. However, children who are very sick with the flu, have a weakened immune system, or have recently taken other specific flu medications may not be able to participate. Those who join the study will receive the medication and will be monitored to see how well it works. This trial is an important step in understanding how to treat influenza effectively in young children.

Gender

ALL

Eligibility criteria

• 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 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 household contact
• \[B\] 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 household contact" criteria
• \[D\] Full-study HHC:
• • Fulfills the "Partial household contact" 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
• Exclusion Criteria (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 fulfill 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