Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653569
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Efficacy of Baloxavir Against Influenza in Hospitalized Patients the INFLUENT Study INpatients InFLUENza Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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 with Symptoms Evolving for More Than 48 Hours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFLUENT
Brief Summary:
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 having flu symptoms for more than 48 hours at hospital admission will be included in the study
The main questions are
1 When someone is hospitalized with a severe influenza infection does baloxavir help to reduce the time needed to recover
2 Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu
3 Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu
4 Can baloxavir reduce duration of contagiousness
To be able to measure the above the investigators will compare two groups of patients One group receiving baloxavir marboxil the other group receiving a mock treatment called placebo
Participants will
Take one single dose of baloxavir marboxil or placebo soon after hospitalization
Vital signs will be followed three times per day during hospital stay
Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation
Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment
The main questions are
1 When someone is hospitalized with a severe influenza infection does baloxavir help to reduce the time needed to recover
2 Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu
3 Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu
4 Can baloxavir reduce duration of contagiousness
To be able to measure the above the investigators will compare two groups of patients One group receiving baloxavir marboxil the other group receiving a mock treatment called placebo
Participants will
Take one single dose of baloxavir marboxil or placebo soon after hospitalization
Vital signs will be followed three times per day during hospital stay
Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation
Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment
Detailed Description:
Background Influenza virus is a major source of seasonal outbreaks and is the leading candidate for a future pandemic Each winter thousands of people are hospitalized with infection complications The most at risk are the very young 5 years the elderly 65 years old and those with a weak immune system When a person is hospitalized because of the flu it is not always clear if the administration of a specific medicine that fights the virus called an antiviral will help
Most studies looked at antivral drug benefits among people with mild flu who didnt need to be hospitalized They found that if the antiviral is started early up to two days after the symptoms started it can make the symptoms go away a little faster But for people in the hospital especially if its been more than two days since their symptoms started it is not so sure if antiviral drugs still help Clinical research involving patients hospitalized for disease complications is few and of lesser quality While some indicate that early treatment might be beneficial there is no scientific agreement about treatment benefits Therefore recommendations and antiviral prescription varies between hospitals and physicians
In Switzerland two antiviral drugs are authorized to treat the flu Tamiflu and Xofluza
Study aims and methods The goal of this industry-independent trial is to measure the benefits of Xofluza compared to placebo mock medication in adult patients hospitalized for the flu
Choice of the medication The investigators chose Xofluza instead of Tamiflu because it is very simple to use only a single pill instead of twice a day Tamiflu for 5 days it has fewer side effects and can be safely given to patients with a wide range of chronic diseases
Importance This study is very important because it could lead to a Swiss and international consensus about the utility of antiviral treatment in hospitalized patients
If beneficial Xofluza might be the drug of choice in a future pandemic when access to a simple to administer and easily stored drug effective at all stages of the illness with few side effects would be of utmost importance
However if the trial doesnt show any benefit of Xofluza administration antiviral treatment prescription wont be recommended preserving patients from unneeded medication and from its potential side effects and saving ressources
Tailoring antiviral use will also help prevent the risk of the virus becoming resistant which might happen in case of overuse
Patient and public involvement During the preparation of the study patient representatives were involved in the development of the research idea in the discussion concerning its ethical aspects the feasibility of recruitment and the selection of questionnaires to measure treatment benefits They participated in the revision of the lay summary as well The informed consent form has been developped together with them in our communication efforts targeting potential participants at the start as well as in the dissemination of the results at the end of the study Patients representatives also developped together with the investigators the strategy of participants recruitment
Most studies looked at antivral drug benefits among people with mild flu who didnt need to be hospitalized They found that if the antiviral is started early up to two days after the symptoms started it can make the symptoms go away a little faster But for people in the hospital especially if its been more than two days since their symptoms started it is not so sure if antiviral drugs still help Clinical research involving patients hospitalized for disease complications is few and of lesser quality While some indicate that early treatment might be beneficial there is no scientific agreement about treatment benefits Therefore recommendations and antiviral prescription varies between hospitals and physicians
In Switzerland two antiviral drugs are authorized to treat the flu Tamiflu and Xofluza
Study aims and methods The goal of this industry-independent trial is to measure the benefits of Xofluza compared to placebo mock medication in adult patients hospitalized for the flu
Choice of the medication The investigators chose Xofluza instead of Tamiflu because it is very simple to use only a single pill instead of twice a day Tamiflu for 5 days it has fewer side effects and can be safely given to patients with a wide range of chronic diseases
Importance This study is very important because it could lead to a Swiss and international consensus about the utility of antiviral treatment in hospitalized patients
If beneficial Xofluza might be the drug of choice in a future pandemic when access to a simple to administer and easily stored drug effective at all stages of the illness with few side effects would be of utmost importance
However if the trial doesnt show any benefit of Xofluza administration antiviral treatment prescription wont be recommended preserving patients from unneeded medication and from its potential side effects and saving ressources
Tailoring antiviral use will also help prevent the risk of the virus becoming resistant which might happen in case of overuse
Patient and public involvement During the preparation of the study patient representatives were involved in the development of the research idea in the discussion concerning its ethical aspects the feasibility of recruitment and the selection of questionnaires to measure treatment benefits They participated in the revision of the lay summary as well The informed consent form has been developped together with them in our communication efforts targeting potential participants at the start as well as in the dissemination of the results at the end of the study Patients representatives also developped together with the investigators the strategy of participants recruitment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None