Efficacy of Baloxavir Against Influenza in Hospitalized Patients: the INFLUENT Study (INpatients InFLUENza Treatment)

Launched by DRE PAULINE VETTER · Oct 20, 2024

Keywords

ClinConnect Summary

The INFLUENT study is a clinical trial investigating whether a medication called baloxavir marboxil (Xofluza®) can help hospitalized patients recover faster from the flu. The trial aims to answer important questions, such as whether this medication can shorten hospital stays, reduce the risk of severe complications or death, and decrease how long someone is contagious. To find out, researchers will compare two groups of patients: one group will receive baloxavir marboxil, while the other will receive a placebo (a treatment that has no active ingredients).

To participate in this study, individuals must be at least 18 years old, have a confirmed influenza infection, and require hospitalization. Participants will receive a single dose of the medication or placebo soon after being hospitalized and will have their vital signs monitored three times a day. They will also provide a nose swab to check for the flu virus and answer a short survey about their quality of life three months later. This study is currently recruiting participants and aims to provide important information about how baloxavir can help those with severe flu.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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 for ≥ 2 weeks, biological therapies, steroid sparing drugs); 3) HIV infection if CD4+ T cell count \< 500/µL; 4) organ or stem cell transplantation; 5) patients on the waiting list for a transplant
• • 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 interventional study with an investigational drug 30 days before inclusion in the study.
• • Unability to consent or patient representative unable to consent.