A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21 days
Maximum Age: 11
Healthy Volunteers: f
View:

• 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 pre-dose examinations at screening is 48 hours or less

⁃ \[A\] IP:

• Eligible to take part in Part A

• Lives in a household with a HHC willing to be recruited as full household contact

⁃ \[B\] 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 with other HHCs (if applicable) who fulfill all the Partial household contact criteria

⁃ \[D\] Full-study HHC:

• Fulfills the Partial household contact 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

Locations
United States
Alabama
Central Alabama Research
RECRUITING
Birmingham
Arkansas
Harrisburg Family Medical Center
RECRUITING
Harrisburg
Florida
Avanza Medical Research Center
RECRUITING
Pensacola
Georgia
Tekton Research - Chamblee Georgia
WITHDRAWN
Chamblee
Tekton Research Lawrenceville
WITHDRAWN
Lawrenceville
Velocity Clinical Research at Primary Pediatrics Macon
TERMINATED
Macon
Idaho
Clinical Research Prime
RECRUITING
Idaho Falls
Kentucky
Kentucky Pediatric Research Center
RECRUITING
Bardstown
Louisiana
Velocity Clinical Research Lafayette
RECRUITING
Lafayette
Velocity Clinical Research, Slidell
COMPLETED
Slidell
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Nevada
Machuca Family Medicine
RECRUITING
Las Vegas
Ohio
Ohio Pediatric Research Association
RECRUITING
Dayton
Pennsylvania
Frontier Clinical Research
RECRUITING
Smithfield
South Carolina
Coastal Pediatric Research
RECRUITING
Charleston
Texas
Tekton Research - Beaumont
RECRUITING
Beaumont
Oak Cliff Research Company, LLC
COMPLETED
Dallas
Oak Cliff Research Company, LLC
RECRUITING
Richardson
Sun Research Institute
RECRUITING
San Antonio
Tekton Research
COMPLETED
San Antonio
Utah
Velocity Clinical Research, Salt Lake City
RECRUITING
West Jordan
West Virginia
Frontier Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Kingwood
Other Locations
Bulgaria
Medical Centre Asklepii, OOD
WITHDRAWN
Dupnitsa
MHAT St. Ivan Rilski Kozloduy
RECRUITING
Kozloduy
MHAT City Clinic - Saint George
RECRUITING
Montana
MHAT Stamen Iliev AD
COMPLETED
Montana
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
COMPLETED
Rousse
MHAT Sliven - Military Medial Academy
RECRUITING
Sliven
AGPSMP Pediatric diseases South park OOD
RECRUITING
Sofia
Medical Center Hera Sofia
COMPLETED
Sofia
Poland
NZOZ Salmed
RECRUITING
??czna
Centrum Medyczne K2J2
RECRUITING
?ód?
IN VIVO Sp. z o.o.
RECRUITING
Bydgoszcz
NZOZ Vitamed
RECRUITING
Bydgoszcz
Centrum Medyczne Pratia Cz?stochowa
RECRUITING
Cz?stochowa
Niepubliczny Zaklad Opieki Zdrowotnej Amed
RECRUITING
Grójec
Vita Longa Sp. z o.o.
RECRUITING
Katowice
NZLA Michalkowice Rybarczyk i partnerzy, Spolka Lekarska
RECRUITING
Siemianowice ?l?skie
Jaroslaw Kierkus Prywatna Prakyka Lekarska
RECRUITING
Warsaw
Centrum Medyczne K2J2
RECRUITING
Wo?omin
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
RECRUITING
Wroc?aw
Spain
Hospital Infantil Universitario Nino Jesus
WITHDRAWN
Madrid
Hospital Universitario 12 de Octubre
WITHDRAWN
Madrid
Complejo Hospitalario Universitario de Santiago (CHUS)
WITHDRAWN
Santiago De Compostela
Hospital Universitari i Politècnic La Fe
COMPLETED
Valencia
Contact Information
Primary
Reference Study ID Number: CV44536 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 750
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov