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Status:

RECRUITING

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Influenza

Eligibility:

All Genders

3-11 years

Phase:

PHASE3

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 22 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2027

    Estimated Enrollment :

    750 Patients enrolled

    Trial Details

    Trial ID

    NCT06094010

    Start Date

    November 22 2023

    End Date

    June 30 2027

    Last Update

    August 6 2025

    Active Locations (45)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (45 locations)

    1

    Central Alabama Research

    Birmingham, Alabama, United States, 35209

    2

    Harrisburg Family Medical Center

    Harrisburg, Arkansas, United States, 72432

    3

    Avanza Medical Research Center

    Pensacola, Florida, United States, 32503

    4

    Tekton Research - Chamblee Georgia

    Chamblee, Georgia, United States, 30341