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

ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-11
SponsorHoffmann-La Roche

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' \<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

This trial does not accept healthy volunteers

Qualifiers

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

Eligible to take part in Part A

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 \[mg/kg\]).

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: Baloxavir MarboxilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions

Time frame
Day 1 (At Baseline)
2

Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions

Time frame
Days 4, 6 and 10

Secondary outcomes

1

Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years)

Time frame
Days 4, 6 and 10
2

Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)

Time frame
Days 4, 6 and 10
3

Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status

Time frame
Days 4, 6 and 10
4

Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)

Time frame
Day 1 (At Baseline)

Other outcomes

1

Percentage of HHCs Who Become PCR (+) for Influenza Bearing a PA/I38X Substitution (or Other Identified Substitution) Including All Data up to Day 15

Time frame
Up to Day 15

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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