An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous (IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection.
This research study is about a medicine called zanamivir, which is given through a drip (intravenously). We are giving this medicine to babies younger than 6 months old who have severe flu that has caused complications. The main goals are to understand how the baby's body handles the medicine, how much stays in their blood, and how quickly it leaves their system. We also want to see if the medicine is safe and if it helps the babies recover from their flu infection. This is an early phase study, meaning we are still gathering initial information to see if this treatment could be a good option for very young children with serious flu.
At a glance
What is this study about?
This study is focused on a medicine called zanamivir that is given into a vein, often called an IV drip. We are looking at how this medicine works in very young babies, specifically those under 6 months old, who have a severe type of influenza, generally known as the flu. Sometimes, the flu can become very serious, especially in babies, leading to complications.
The main aim is to understand how the baby's body processes the medicine. This includes how long it stays in their blood, how much of it reaches their system, and how quickly their body gets rid of it. We also want to carefully watch for any side effects and see if the medicine helps these babies get better from their severe flu. Because this is an early study (a Phase II trial), we are still exploring whether this treatment is generally safe and potentially helpful for this vulnerable group.
Finding safe and effective ways to treat severe flu in babies is really important, as they can become very unwell. This study is a step towards understanding if zanamivir, given this way, could be a future option for them.
Key takeaways
- This study is for babies under 6 months old with severe flu.
- It uses an existing flu medicine, zanamivir, given by a drip.
- The main goals are to check the medicine's safety and how it works in babies' bodies.
- Doctors will carefully monitor your baby's health.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for babies who have a confirmed serious flu infection and are under 6 months old. Both boys and girls can take part in this research.
Key things that mean a baby might be eligible are having a flu infection that has been confirmed by a doctor and being less than six months old, right from birth up to just under six months.
Your doctor will be able to confirm if your baby meets all the necessary health criteria for taking part in this specific study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my baby under 6 months old?
- Does my baby have a confirmed flu infection?
- Has a doctor told me my baby's flu is considered 'complicated' or severe?
- Is my baby able to receive medicine through an IV drip?
- Am I comfortable with my baby having blood tests and close medical monitoring?
What does participation involve?
If your baby takes part in this study, they will receive the study medicine, zanamivir, through an IV drip. The doctors will take regular blood samples to see how the medicine is working in your baby's body and check for any side effects. They will also do regular health checks and tests to monitor your baby's flu symptoms and overall health.
The medical team will explain the specific schedule of visits and tests, but it will involve several appointments while your baby is receiving the medicine and potentially some follow-up visits after the medicine has stopped to ensure your baby is recovering well. The total duration of your baby's involvement in the study will be clearly explained by the study team, from the first dose of medicine to the final health check.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is zanamivir?
Zanamivir is a medicine used to treat flu. In this study, we are giving it through a drip to see how it works in very young babies with severe flu.
What is 'intravenous' (IV) treatment?
Intravenous means the medicine is given directly into a vein, usually through a small tube or drip, so it can quickly get into the bloodstream.
Why are you studying this in babies?
Babies can get very sick with flu, and we need to find the best and safest ways to treat them. This study investigates if this medicine can help.
Will my baby get better if they are in this study?
We hope the medicine will help, but this is a research study to find out more. We cannot guarantee your baby will get better from participation in the study itself.
What do you mean by 'complicated influenza'?
This means your baby's flu infection is severe and has led to other health problems or serious symptoms, as diagnosed by their doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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