Trial studying safety and effects for Influenza Disease; Flu
Official title Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)
ClinicalTrials.gov ID: NCT06653569
What this study is testing
What is Baloxavir Marboxil?
Baloxavir Marboxil is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for influenza disease; flu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Participant or participant representative capable of giving signed informed consent.
- Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
- Patient requiring hospitalization.
- National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization
You likely can't join if
- Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
- Known contraindication to baloxavir or to the placebo
- Participant weighing \< 40 kg
- Patients already on NAI therapy for the current influenza episode for \> 24 hours at the time of randomization.
- Prior treatment with baloxavir for the current influenza epidose
- Immunosuppression defined as 1) cancer treatment with significant negative effect on the immune system; 2) immunosuppressive therapy (treatments...
See the full eligibility criteria
- Age ≥ 18 years
- Participant or participant representative capable of giving signed informed consent.
- Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
- Patient requiring hospitalization.
- National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization
- Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
- Known contraindication to baloxavir or to the placebo
- Participant weighing \< 40 kg
- Patients already on NAI therapy for the current influenza episode for \> 24 hours at the time of randomization.
- Prior treatment with baloxavir for the current influenza epidose
- Immunosuppression defined as 1) cancer treatment with significant negative effect on the immune system; 2) immunosuppressive therapy (treatments comprising a dose of ≥20 mg/day prednisone or equivalent when administered...
- Severe underlying respiratory comorbidity requiring long-term oxygenotherapy at home.
- Severe disease requiring ICU care directly at hospitalization.
- Severe hepatic insufficiency or any other severe medical condition when participation in the study puts the patient at risk according to the investigator's judgment.
- History of inclusion in this study during a previous influenza season
- Inclusion in another treatment study with an investigational drug 30 days before inclusion in the study.
- Unability to consent or patient representative unable to consent.
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland. 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 ClinicalTrials.gov; the study team decides eligibility.