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

Study acronym: Pebblestone
StatusRecruiting
PhasePhase 3
Started2023-11-22
View on ClinicalTrials.gov ↗

Amendment history

2026-04-27
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v24
Enrollment increased: 750 → 1100 participants
Eligibility criteria-33 characters
[...] rticipants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screen [...] ng Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less Incl [...] s in a household with a HHC willing to be recruited as full household contactHHC [B] HHCs: - Each HHC living in the home of an IP at the tim [...] ld where 1 or more HHCs meet the full-study HHC requirements, ANDand at least 1 full-study HHC has not received the influenza va [...] lives with other HHCs (if applicable) who fulfill all the "Partialpar [...] [...]
Secondary endpointsdetails revised at 2 of 9 entries
2026-04-02
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 51 sites
2026-03-05
Study Status, Contacts/Locations v22
Study sites51 entries, revised
Centrum Medyczne Pratia Cz?stochowaCzęstochowa
2026-02-06
Study Status, Contacts/Locations v21
Study sitesdetails revised at 2 of 51 sites
2026-01-09
Study Status, Contacts/Locations v20
Study sites45→51
Show 19 earlier versions
2025-08-01
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v19
Enrollment target600→750
Eligibility criteria+1,834 characters
Inclusion Criteria (Part A): Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test [...] 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 H [...] Exclusion Criteria (Part A): Participants with severe influenza vir [...] [...]
Secondary endpoints7 to 9 entries
Part A: Percentage of ParticipantsIPs withWith Resistance-Associatedassociated Treatment-Emergentemergent Substitutions by Age Groups (<5 yearsYears versus[< 1 Year, ≥ 1 Year to < 5 yearsYears], and 5 to < 12 Years) Part A: Percentage of ParticipantsIPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA) Part A: Percentage of ParticipantsIPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status Part A: Percentage of ParticipantsIPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3) Part A: Change From Baseline in Viral Titer [...] [...]
Primary endpoints2 entries, revised
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions
Study title+62 characters
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
2025-06-27
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v18
Eligibility criteria-10 characters
[...] l influenza test within 24 hours before full study screening. Participants with a negative severe acute respiratory syndr [...] SARS-CoV-2) test within 48 hours before full study screening. Time interval between onset of influenza symptoms and the p [...] vere influenza virus infection requiring inpatient treatment. Severely immunocompromised participants [including particip [...] ciency virus (HIV) infection] as defined by the investigator. Participants with concurrent (non-influenza) infections req [...] obial and/or anti-viral therapy at the pre-dose examinations. Treatment with baloxavir marboxil, peramivir, laninami [...] [...]
Secondary endpoints7 entries, revised
Percentage of Participants withWith Novel Treatment-Emergentemergent Mutations in Polymerase Acidic Protein (PA) Percentage of Participants withWith Resistance-Associatedassociated Treatment-Emergentemergent Substitutions by Baseline Vaccination Status Percentage of Participants withWith Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3) Change fromFrom Baseline in Viral Titers by Quantitative Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) Susceptibility to Baloxavir Marboxil by Phenotyping Post-Baselineof SamplesVirus withWith Novel Genotypic PA Substitutions Number of Partic [...] [...]
Primary endpoints2 entries, revised
Percentage of Participants withWith Resistance-Associatedassociated Pre-Treatmenttreatment Substitutions Percentage of Participants withWith Resistance-Associatedassociated Treatment-Emergentemergent Substitutions
Study sitesdetails revised at 3 of 45 sites
2025-02-13
Study Status, Contacts/Locations v17
Study sitesdetails revised at 2 of 45 sites
2025-01-14
Study Status, Contacts/Locations v16
Study sites43→45
2024-12-15
4 amendments v12-v15
4 re-verifications since 2024-09-17, no change to tracked fields
2024-08-19
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 43 sites
2024-07-18
Study Status v10
Re-verified, no change to tracked fields
2024-06-21
Study Status, Contacts/Locations v9
Study sitesdetails revised at 2 of 43 sites
2024-05-24
Study Status, Eligibility, Contacts/Locations v8
Eligibility criteria-8 characters
[...] RS-CoV-2) test within 48 hours before full study screening. The timeTime interval between the onset of influenza symptoms and the pre-dose examinations a [...]
Study sitesdetails revised at 4 of 43 sites
2024-04-30
Study Status v7
Re-verified, no change to tracked fields
2024-03-31
Study Status, Contacts/Locations v6
Study sitesdetails revised at 3 of 43 sites
2024-03-01
Study Status, Contacts/Locations v5
Study sites42→43
2024-02-02
Study Status, Contacts/Locations v4
Study sitesdetails revised at 5 of 42 sites
2024-01-05
Study Status, Contacts/Locations v3
Study sites21→42
2023-12-07
Study Status, Contacts/Locations v2
Start dateestimated 2023-11-30→confirmed 2023-11-22
Study sites2→21
2023-11-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-11-05→2023-11-30
Study sites0→2
2023-10-17
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT06094010
Lead Sponsor Hoffmann-La Roche
Conditions Influenza
Enrollment 1,100 participants
Start Date 2023-11-22
Primary Completion 2027-05-11 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24