An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection
This study is for babies under 6 months old who are in hospital because of flu. Currently, there isn't a specific flu treatment available for this very young age group, so this study aims to help fill that gap. We want to understand how their bodies process a medicine called zanamivir when given through a drip (intravenous). The study will also carefully check if the medicine is safe and if babies can tolerate it well. This research is important because babies this young have delicate immune systems and can't get flu vaccines yet, making them vulnerable to serious flu infections.
At a glance
What is this study about?
This study is looking into a medicine called zanamivir, given directly into a vein (intravenous or IV), for very young babies. Specifically, we're focusing on infants under 6 months old who are in the hospital because they have the flu. Flu can be very serious, especially for young children whose bodies are still developing and who can't yet have the flu vaccine.
While this medicine has been used and studied in older children and adults, we don't know enough about how it works and if it's safe for babies under 6 months. This study aims to understand how their bodies handle the medicine (this is called pharmacokinetics) and to carefully watch for any side effects, ensuring it's well-tolerated. This information is really important because it could help doctors treat future babies who get severe flu.
This research is being done on behalf of GlaxoSmithKline (GSK), a pharmaceutical company. It's a requirement from European health authorities to make sure new medicines are properly studied in all age groups, including the very youngest patients, especially when there aren't many other treatment options available for them.
Key takeaways
- New study for babies under 6 months with flu.
- Investigating intravenous flu medicine (zanamivir).
- Focus on how medicine works and its safety in very young infants.
- Treatment up to 10 days, follow-up for 14 days.
- Learning outcomes will help future babies with flu.
- Parents can withdraw their baby at any time.
Who may be eligible?
To be part of this study, babies must be under 6 months old and in the hospital because they have been diagnosed with the flu. This diagnosis will be confirmed by special tests. They also need to weigh at least 1 kilogram (about 2.2 pounds).
Parents or legal guardians must be willing and able to give written permission for their baby to join the study. If a baby was born early, they must have reached at least 28 weeks of age since their conception (sometimes called corrected age).
Babies would not be able to join if they are allergic to the study medicine, have a severe, untreatable illness, or have certain serious liver problems identified by blood tests. The medical team will carefully check all these details to make sure the study is right and safe for your baby.
- Is your baby less than 6 months old?
- Is your baby currently in hospital with confirmed flu?
- Does your baby weigh at least 1 kilogram (about 2.2 pounds)?
- Are you, as a parent or legal guardian, willing and able to give written permission?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your baby takes part, they will receive the study medicine, zanamivir, through a drip into a vein. They will typically receive this treatment for 5 days, but if the doctor thinks it's necessary based on their symptoms or test results, the treatment might be extended for up to another 5 days. For example, if your baby is still very unwell, the doctors may decide to continue the medication for longer.
During the study, doctors and nurses will regularly check your baby's health, take blood samples to see how the medicine is working in their body, and monitor for any side effects. After the treatment period finishes, there will be follow-up checks for 14 days to make sure your baby is recovering well. The total time your baby would be involved in the study, from starting the medicine to the final check-up, could be up to 24 days.
Potential risks and benefits
Locations (9)
- GSK Investigational SiteFlorence, Italy· Recruiting
- GSK Investigational SiteMessina, Italy· Recruiting
- GSK Investigational SiteMilan, Italy· Recruiting
- GSK Investigational SiteRoma, Italy· Recruiting
- GSK Investigational SiteBydgoszcz, Poland· Completed
- GSK Investigational SiteBarcelona, Spain· Recruiting
- GSK Investigational SiteMadrid, Spain· Recruiting
- GSK Investigational SiteLondon, United Kingdom· Recruiting
- GSK Investigational SiteLondon, United Kingdom· Recruiting
Common questions
What is the main purpose of this study?
The main purpose is to understand how a flu medicine called zanamivir works in babies under 6 months old and if it's safe for them.
What is zanamivir?
Zanamivir is a medicine used to treat flu, given through a drip in this study for young babies.
How long will my baby be in the study?
Your baby could be in the study for up to 24 days in total, including treatment time and follow-up checks.
Can my baby get the flu vaccine instead?
No, flu vaccines are not currently licensed for children under 6 months old, which is why this research is so important.
What if I change my mind after my baby starts the study?
You can withdraw your baby from the study at any time without it affecting their care.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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