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

Conditions

• Influenza

Eligibility Criteria

Sex

ALL

Age

3 Weeks - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Baloxavir Marboxil — DRUG
  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 milligrams per kilogram \[mg/kg\]).

Study Details

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.

Key Dates

Start date

Nov 22, 2023

Status verified

Apr 2026

Primary completion

May 11, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

1,100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions [ Time Frame: Day 1 (At Baseline) ]

Central Contacts

• Reference Study ID Number: CV44536 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]

Locations (28)

Find similar trials in Birmingham, AL

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