A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts
Hoffmann-La Roche
750 participants
Nov 22, 2023
INTERVENTIONAL
Conditions
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 pediatric participants' susceptibility \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs.
Eligibility
Inclusion Criteria20
- 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
- \[A\] 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 Criteria11
- 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)
- 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
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Interventions
Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms (kg): 80 milligrams (mg); ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 mg/kg).
Locations(51)
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NCT06094010