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    A clinical trial to look at how well baloxavir reduces the spread of the flu within households, compared with a placebo (no active treatment).

    Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households (CENTERSTONE)

    • Infectious Diseases
    • Influenza

    Basic Details

    Gender
    All
    Age
    ≥5 Years & ≤ 64 Years
    Healthy Volunteers
    No
    Sponsor Hoffmann-La Roche
    Phase Phase 3
    Study Identifier NCT03969212, MV40618, 2018-004056-37

    How does the CENTERSTONE clinical trial work?

    This clinical trial is recruiting people who have a disease called influenza, which is more commonly known as the flu. In order to take part, you must be living with at least two people who have not had the flu vaccine within the last 6 months and who show no signs of having the flu. All of the people that you live with should also be willing to have swabs taken from their noses.

    The purpose of this clinical trial is to test how well baloxavir can reduce the spread of flu within your home, compared with a placebo. If you take part in this clinical trial, you will receive either baloxavir or a placebo.

    How do I take part in this clinical trial?
    To be able to take part in this clinical trial, you must have been diagnosed with the flu and your symptoms must have started within the last 2 days. You must be between 12 and 64 years of age. You must live with at least two people who have not had the flu vaccine in the last 6 months and who show no signs of the flu. All of the people that you live with should also be willing to have swabs taken from their noses.

    You must not have been given treatment for the flu in the last 30 days and you must not be pregnant or immunocompromised (have a weakened immune system). You must not live with anyone who is pregnant, immunocompromised or under the age of 2.

    If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

    You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

    Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

    While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.

    What treatment will I be given if I join this clinical trial?

    Everyone who joins this clinical trial will be split into 2 groups randomly (like flipping a coin) and given either:

    ●        baloxavir, given as a tablet to swallow once

    ●        OR placebo, given as a tablet to swallow once

    You will have an equal chance of being placed in any group.

    This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given medicine with no active ingredients (also known as a ‘placebo’). A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial.

    Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk

    How often will I be seen in follow-up appointments, and for how long?

    You will be given the clinical trial treatment only once. After being given treatment, a nurse will visit your home to check that the other people that you live with meet the requirements for the trial and take swabs from their noses to check for the flu virus. The nurse will then visit your home every couple of days to check how you are responding to the treatment and monitor any side effects that you may be having. They will also monitor the people that you live with to see if they get flu symptoms during the trial. The nurse will take further swabs from you and the people you live with during these visits. Your swabs will be tested to confirm if the amount of flu virus in your body is going down. The swabs taken from your family will be tested to see if any of them have caught the flu virus. These visits will stop about 9 days after you are given treatment. Any or all home visit assessments can be conducted at the clinic if you or the people you live with prefer to visit the clinic.

    You and the people you live with are free to leave this clinical trial at any time.

    What happens if I am unable to take part in this clinical trial?

    If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03969212

    Trial-identifier: NCT03969212

    What happens if I am unable to take part in this clinical trial?

    If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on this page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT03969212?term=MV40618&rank=1

    Trial-identifier: NCT03969212

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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