A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Start Date
11/22/2023
Completion Date
6/30/2027
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 Criteria
Age Range: No minimum to 11 years
Interventions
Baloxavir Marboxil
Conditions
Locations
Central Alabama Research
Birmingham, Alabama 35209
United States
Harrisburg Family Medical Center
Harrisburg, Arkansas 72432
United States
Kendall South Medical Center Inc.
Miami, Florida 33185
United States
Avanza Medical Research Center
Pensacola, Florida 32503
United States
Tekton Research - Chamblee Georgia
Chamblee, Georgia 30341
United States
Tekton Research Lawrenceville
Lawrenceville, Georgia 30043
United States
Velocity Clinical Research at Primary Pediatrics Macon
Macon, Georgia 31210
United States
Clinical Research Prime
Idaho Falls, Idaho 83404
United States
Mishawaka Osteopathic Clinic
Mishawaka, Indiana 46544
United States
Kentucky Pediatric Research Center
Bardstown, Kentucky 40004
United States
Velocity Clinical Research Lafayette
Lafayette, Louisiana 70508
United States
Velocity Clinical Research, Slidell
Slidell, Louisiana 31210
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United States
Machuca Family Medicine
Las Vegas, Nevada 89104
United States
Ohio Pediatric Research Association
Dayton, Ohio 45414
United States
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights, Ohio 44130-3643
United States
Frontier Clinical Research
Smithfield, Pennsylvania 15478
United States
Coastal Pediatric Research
Charleston, South Carolina 29414
United States
Tekton Research - Beaumont
Beaumont, Texas 77706
United States
Oak Cliff Research Company, LLC
Dallas, Texas 75287
United States
Mercury Clinical Research
Houston, Texas 77087
United States
Pioneer Research Solutions
Houston, Texas 77099
United States
Oak Cliff Research Company, LLC
Richardson, Texas 75287
United States
Sun Research Institute
San Antonio, Texas 78215
United States
Tekton Research
San Antonio, Texas 78229
United States
Siena Research Network
Sugar Land, Texas 77479
United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
United States
Frontier Clinical Research, LLC
Kingwood, West Virginia 26537
United States
Medical Centre "Asklepii", OOD
Dupnitsa, 2600
Bulgaria
MHAT " St. Ivan Rilski " Kozloduy
Kozloduy, 3320
Bulgaria
MHAT Stamen Iliev AD
Montana, 3400
Bulgaria
MHAT City Clinic - Saint George
Montana, 3403
Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
Rousse, 7002
Bulgaria
MHAT Sliven - Military Medial Academy
Sliven, 8800
Bulgaria
AGPSMP Pediatric diseases South park OOD
Sofia, 1421
Bulgaria
Medical Center Hera Sofia
Sofia, 1510
Bulgaria
IN VIVO Sp. z o.o.
Bydgoszcz, 85-048
Poland
NZOZ Vitamed
Bydgoszcz, 85-079
Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, 42-200
Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
Grójec, 05-600
Poland
Vita Longa Sp. z o.o.
Katowice, 40-748
Poland
Centrum Medyczne K2J2
Lodz, 92-108
Poland
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
Siemianowice Śląskie, 41-103
Poland
Jaroslaw Kierkus Prywatna Prakyka Lekarska
Warsaw, 04-501
Poland
Centrum Medyczne K2J2
Wo?omin, 05-200
Poland
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroclaw, 53-149
Poland
NZOZ Salmed
Łęczna, 21-010
Poland
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna 15706
Spain
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Spain