A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Baloxavir Marboxil: 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 milligrams per kilogram \[mg/kg\]).
Study 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' \<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. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.
Eligibility
Sex
ALL
Min age
3 Weeks
Max age
11 Years
Healthy volunteers
No
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 start of 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 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 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 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
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 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
Primary outcome measure(s)
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions — Day 1 (At Baseline)
Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions — Days 4, 6 and 10
Trial sites (51)
Facility
City
Region
Status
Central Alabama Research
Birmingham
Alabama
Recruiting
Harrisburg Family Medical Center
Harrisburg
Arkansas
Recruiting
Kendall South Medical Center Inc.
Miami
Florida
Recruiting
Avanza Medical Research Center
Pensacola
Florida
Recruiting
Tekton Research - Chamblee Georgia
Chamblee
Georgia
Withdrawn
Tekton Research Lawrenceville
Lawrenceville
Georgia
Withdrawn
Velocity Clinical Research at Primary Pediatrics Macon
Macon
Georgia
Completed
Clinical Research Prime
Idaho Falls
Idaho
Recruiting
Mishawaka Osteopathic Clinic
Mishawaka
Indiana
Recruiting
Kentucky Pediatric Research Center
Bardstown
Kentucky
Recruiting
Velocity Clinical Research Lafayette
Lafayette
Louisiana
Recruiting
Velocity Clinical Research, Slidell
Slidell
Louisiana
Completed
Velocity Clinical Research, Grand Island
Grand Island
Nebraska
Recruiting
Machuca Family Medicine
Las Vegas
Nevada
Recruiting
Ohio Pediatric Research Association
Dayton
Ohio
Recruiting
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights
Ohio
Recruiting
Frontier Clinical Research
Smithfield
Pennsylvania
Recruiting
Coastal Pediatric Research
Charleston
South Carolina
Recruiting
Tekton Research - Beaumont
Beaumont
Texas
Recruiting
Oak Cliff Research Company, LLC
Dallas
Texas
Completed
Mercury Clinical Research
Houston
Texas
Completed
Pioneer Research Solutions
Houston
Texas
Recruiting
Oak Cliff Research Company, LLC
Richardson
Texas
Recruiting
Sun Research Institute
San Antonio
Texas
Withdrawn
Tekton Research
San Antonio
Texas
Completed
Siena Research Network
Sugar Land
Texas
Recruiting
Velocity Clinical Research, Salt Lake City
West Jordan
Utah
Recruiting
Frontier Clinical Research, LLC
Kingwood
West Virginia
Active Not Recruiting
Medical Centre "Asklepii", OOD
Dupnitsa
Bulgaria
Completed
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy
Bulgaria
Recruiting
MHAT Stamen Iliev AD
Montana
Bulgaria
Completed
MHAT City Clinic - Saint George
Montana
Bulgaria
Recruiting
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse
Bulgaria
Completed
MHAT Sliven - Military Medial Academy
Sliven
Bulgaria
Recruiting
AGPSMP Pediatric diseases South park OOD
Sofia
Bulgaria
Recruiting
Medical Center Hera Sofia
Sofia
Bulgaria
Completed
IN VIVO Sp. z o.o.
Bydgoszcz
Poland
Recruiting
NZOZ Vitamed
Bydgoszcz
Poland
Recruiting
Centrum Medyczne Pratia Częstochowa
Częstochowa
Poland
Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grójec
Poland
Recruiting
+ 11 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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