Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 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 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 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 Exclusion Criteria (Part A): ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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 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 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 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 fulfill 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

Treatments Being Tested

DRUG

Baloxavir Marboxil

Baloxavir marboxil will be administered as an oral suspension per body weight (≥80 kilograms (kg): 80 milligrams (mg); ≥20 kg to \< 80 kg: 40 mg; \<20 kg: 2 mg/kg).

Locations (20)

Central Alabama Research
Birmingham, Alabama, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Kendall South Medical Center Inc.
Miami, Florida, 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
Mishawaka Osteopathic Clinic
Mishawaka, Indiana, 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
Helios Clinical Research, Inc (former Ventavia Research Group)
Middleburg Heights, 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
Dallas, Texas, United States