A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Recruiting now · Phase 3
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT06094010
- Run by
- Hoffmann-La Roche
- People needed
- 1100
- Starts
- 2023-11-22
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-01
Who can join
Age: 0 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States (enrolling)
- IN VIVO Sp. z o.o. — Bydgoszcz, Poland (enrolling)
- Avanza Medical Research Center — Pensacola, Florida, United States (enrolling)
- Siena Research Network — Sugar Land, Texas, United States (enrolling)
- MHAT Sliven - Military Medial Academy — Sliven, Bulgaria (enrolling)
- AGPSMP Pediatric diseases South park OOD — Sofia, Bulgaria (enrolling)
- Clinical Research Prime — Idaho Falls, Idaho, United States (enrolling)
- Mishawaka Osteopathic Clinic — Mishawaka, Indiana, United States (enrolling)
- Central Alabama Research — Birmingham, Alabama, United States (enrolling)
- Velocity Clinical Research Lafayette — Lafayette, Louisiana, United States (enrolling)
- MHAT City Clinic - Saint George — Montana, Bulgaria (enrolling)
- Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States (enrolling)
- Machuca Family Medicine — Las Vegas, Nevada, United States (enrolling)
- Ohio Pediatric Research Association — Dayton, Ohio, United States (enrolling)
- Helios Clinical Research, Inc (former Ventavia Research Group) — Middleburg Heights, Ohio, United States (enrolling)
- Frontier Clinical Research — Smithfield, Pennsylvania, United States (enrolling)
- Coastal Pediatric Research — Charleston, South Carolina, United States (enrolling)
- Tekton Research - Beaumont — Beaumont, Texas, United States (enrolling)
- Kentucky Pediatric Research Center — Bardstown, Kentucky, United States (enrolling)
- Harrisburg Family Medical Center — Harrisburg, Arkansas, United States (enrolling)
- Pioneer Research Solutions — Houston, Texas, United States (enrolling)
- Oak Cliff Research Company, LLC — Richardson, Texas, United States (enrolling)
- Kendall South Medical Center Inc. — Miami, Florida, United States (enrolling)
- MHAT " St. Ivan Rilski " Kozloduy — Kozloduy, Bulgaria (enrolling)
- NZOZ Vitamed — Bydgoszcz, Poland (enrolling)
Full record on ClinicalTrials.gov
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