A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza

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:
• • Participants with symptoms suggestive of influenza 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
• Exclusion Criteria:
• • 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)