A Surveillance Study of Susceptibility to Baloxavir Marboxil in Participants With Influenza
- Registration Number
- NCT06094010
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to evaluate the pre-treatment and single-dose post treatment susceptibility of baloxavir marboxil in participants aged 1 to \<12 years with influenza.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Participants with symptoms suggestive of influenza 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
- 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).
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).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Resistance-Associated Pre-Treatment Substitutions Day 1 (Baseline) Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions Days 4, 6 and 10
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Age Groups (<5 years versus ≥ 5 years) Days 4, 6 and 10 Percentage of Participants with Novel Treatment-Emergent Mutations in Polymerase Acidic Protein (PA) Days 4, 6 and 10 Percentage of Participants with Resistance-Associated Treatment-Emergent Substitutions by Baseline Vaccination Status Days 4, 6 and 10 Percentage of Participants with Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3) Day 1 (Baseline) Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baseline Samples with Novel Genotypic PA Substitutions Days 4, 6 and 10 Number of Participants with Adverse Events and Serious Adverse Events Up to Day 29 Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Change from Baseline in Viral Titers by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Baseline (Day 1); Days 4, 6 and 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
Velocity Clinical Research, Grand Island
🇺🇸Grand Island, Nebraska, United States
Machuca Family Medicine
🇺🇸Las Vegas, Nevada, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Frontier Clinical Research
🇺🇸Smithfield, Pennsylvania, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Tekton Research - Beaumont
🇺🇸Beaumont, Texas, United States
Oak Cliff Research Company, LLC
🇺🇸Richardson, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Tekton Research
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Frontier Clinical Research, LLC
🇺🇸Kingwood, West Virginia, United States
Medical Centre "Asklepii", OOD
🇧🇬Dupnitsa, Bulgaria
MHAT " St. Ivan Rilski " Kozloduy
🇧🇬Kozloduy, Bulgaria
MHAT Stamen Iliev AD
🇧🇬Montana, Bulgaria
MHAT City Clinic - Saint George
🇧🇬Montana, Bulgaria
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
🇧🇬Ruse, Bulgaria
MHAT Sliven - Military Medial Academy
🇧🇬Sliven, Bulgaria
AGPSMP Pediatric diseases South park OOD
🇧🇬Sofia, Bulgaria
Medical Center Hera Sofia
🇧🇬Sofia, Bulgaria
NZOZ Salmed
🇵🇱??czna, Poland
Centrum Medyczne K2J2
🇵🇱Wo?omin, Poland
IN VIVO Sp. z o.o.
🇵🇱Bydgoszcz, Poland
NZOZ Vitamed
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Pratia Cz?stochowa
🇵🇱Cz?stochowa, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Amed"
🇵🇱Grojec, Poland
Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
🇵🇱Siemianowice ?l?skie, Poland
Jaroslaw Kierkus Prywatna Prakyka Lekarska
🇵🇱Warszawa, Poland
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
🇵🇱Wroc?aw, Poland
Complejo Hospitalario Universitario de Santiago (CHUS)
🇪🇸Santiago de Compostela, LA Coruna, Spain
Hospital Infantil Universitario Nino Jesus
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain