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NCT06094010PHASE3Recruiting

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Hoffmann-La Roche

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

Inclusion Criteria (Part A): * 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 start of pre-dose examinations at screening is 48 hours or less Inclusion Criteria (Part B): \[A\] IP: * Eligible to take part in Part A * Lives in a household with a HHC willing to be recruited as full HHC \[B\] 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 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 HHC" criteria \[D\] Full-study HHC: * Fulfills the "partial HHC" 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 Exclusion Criteria (Part A): * 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) Exclusion Criteria (Part B): * IPs who fulfil an exclusion criterion for Part A * HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice * HHCs diagnosed with influenza by health care professional in the past 4 weeks

Interventions

DRUG

Baloxavir Marboxil

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Conditions

Influenza

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