INFLUENT
A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Swiss National Science Foundation
interventional
484
1 country
1
Study Start
December 13, 2024
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. The main questions are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2024
Actual (reported)October 22, 2024
Actual (reported)December 13, 2024
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time to clinical improvement
The primary outcome is the time to clinical improvement, calculated from treatment administration, assessed by time to hospital discharge alive or time to a NEWS2 score of 2 or lower maintained for 24 h, whichever comes first.
From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90
Clinical status severity score
At 7 days post treatment administration
Duration of hospitalization
From treatment administration to hospital discharge, assessed up to day 90
Duration of Oxigen supplementation
From treatment administration to waining of oxygen therapy, assessed up to day 90 (in patients requiring oxygen).
In-hospital clinical failure
From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
Mortality
From treatment administration during 90 days
Serious adverse events, SAR and SUSAR
From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
baloxavir marboxil
Pacebo
The antiviral baloxavir marboxil administered in one unique dose. 1 capsule (40 mg) if participant weighs \< 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg
Patients in the placebo group will receive one unique dose of placebo. 1 capsule if participant weighs \< 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg.
Geneva University Hospitals
Geneva, Canton of Geneva, 1205, Switzerland
Hosszu-Fellous K, Vetter P, Agoritsas T, Kaiser L. Which trial do we need? Randomized, placebo-controlled trial of antiviral treatment in patients hospitalized for influenza. Clin Microbiol Infect. 2024 May;30(5):567-569. doi: 10.1016/j.cmi.2024.01.025. Epub 2024 Feb 3. No abstract available.
Hosszu-Fellous K, Poncet A, Cabecinhas ARG, Schibler M, Meyer B, Prendki V, Huttner A, Carballo S, Pouillon M, Slankamenac K, Bart PA, Bernasconi E, Manuel O, Mombelli M, Mueller NJ, Kaiser L, Vetter P. Antiviral treatment in adult patients hospitalized for influenza: study protocol for a multi-center, randomized, placebo-controlled trial on the efficacy of baloxavir marboxil to reduce time to clinical improvement and the risk for severe complications (the INFLUENT trial). Trials. 2025 Nov 24;26(1):538. doi: 10.1186/s13063-025-09248-0.
Pauline Vetter, MD
University Hospital, Geneva
Nicolas Muller, Professor
Department of Infectious Diseases and Hospital epidemiology, University Hospital Zürich
Matteo Mombelli, MD
Department of internal medicine, Locarno Regional Hospital EOC
Oriol Manuel, Pr
Center for organ transplantation, Lausanne University Hospitals
First Submitted
October 18, 2024
First Posted
October 22, 2024
Study Start
December 13, 2024
Actual (reported)Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 1, 2026
Record last verified: 2026-04
The investigators plan to share individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). IPD can be shared with investigators whose proposed use of the data has been approved by an independent review committee, for, as an example, individual participant data meta-analysis. The approval of the biobank regulation committee, which includes the coordinating PI, the sites PI and the responsibles of the biobank is also required on a case by case basis.
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Source: ClinicalTrials.gov.
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