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A Study of Susceptibility to Baloxavir Marboxil in Patients with Influenza and its transmission to their household contacts
EU CTIS ID: 2023-504672-22-00
What this study is testing
Part A (Surveillance) To evaluate the prevalence of pre-dose and treatment-emergent polymerase acidic protein (PA) I38X and T20K substitutions and other resistance-associated PA substitutions by type and subtype of influenza virus from patients treated with baloxavir marboxil
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part A (Surveillance) Patients with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test [rapid influenza diagnostic test (RIDT), or Liat®, or polymerase chain react (PCR); for European Union (EU) sites, the test must be in compliance with In Vitro Diagnostic Regulation (IVDR)] within 24 hours before full study screening
- Part A (Surveillance) Patients with a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (rapid diagnostic test, or Liat®, or PCR; for E.U. sites, the test must be in compliance with IVDR) within 48 hours before full study screening
- Part A (Surveillance) The time interval of 48 hours or less between the onset of influenza symptoms and the start of pre-dose examinations at screening
- Part A (Surveillance) Patients or their parents/caregivers who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the pre-dose examinations appropriately
You likely can't join if
- Part A (Surveillance) Patients with severe influenza virus infection requiring inpatient treatment
- Part A (Surveillance) Severely immunocompromised patients [including patients receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus (HIV) infection] as defined by the investigator
- Part A (Surveillance) Patients with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations
- Part A (Surveillance) Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening
- Part A (Surveillance) Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives whichever is longer and/or an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
- Part A (Surveillance) Known hypersensitivity to baloxavir marboxil or the drug product excipients
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.