A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
- Registration Number
- NCT06094010
- Lead Sponsor
- Hoffmann-La Roche
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baloxavir Marboxil Baloxavir Marboxil Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment. Baloxavir Marboxil Baloxavir Marboxil Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
- Primary Outcome Measures
Name Time Method Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions Day 1 (Baseline) Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions Days 4, 6 and 10
- Secondary Outcome Measures
Name Time Method Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years) Days 4, 6 and 10 Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA) Days 4, 6 and 10 Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status Days 4, 6 and 10 Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3) Day 1 (Baseline) Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Baseline (Day 1); Days 4, 6 and 10 Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions Days 4, 6 and 10 Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to Day 29 AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP Day 6, Day 10 Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP Day 6, Day 10
Trial Locations
- Locations (43)
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Tekton Research - Chamblee Georgia
🇺🇸Chamblee, Georgia, United States
Tekton Research Lawrenceville
🇺🇸Lawrenceville, Georgia, United States
Velocity Clinical Research at Primary Pediatrics Macon
🇺🇸Macon, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Kentucky Pediatric Research Center
🇺🇸Bardstown, Kentucky, United States
Velocity Clinical Research Lafayette
🇺🇸Lafayette, Louisiana, United States
Velocity Clinical Research, Slidell
🇺🇸Slidell, Louisiana, United States
Scroll for more (33 remaining)Central Alabama Research🇺🇸Birmingham, Alabama, United States