A Phase 1, Multicentre, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single IV Dose of Rezafungin Acetate in Paediatric Subjects from Birth to <18 Years of Age, Receiving Systemic Antifungals as Prophylaxis for Invasive Fungal Infection or to Treat a Suspected or Confirmed Fungal Infection
This study, called 'REZZAYO for Fungal Infections in Children', is looking at a new medicine for fungal infections in children and teenagers (from babies up to 17 years old). It's a very early-stage study (Phase 1) to understand how the medicine works in the body. We are checking how the medicine moves through the body, how long it stays, and how it's removed. We also want to make sure it's safe and that children can tolerate it well. The medicine, REZZAYO, is given through a drip into a vein. This study helps us learn important information before it can be explored in more people.
At a glance
What is this study about?
Fungal infections can be serious, especially for children who are already unwell. This study is testing a new medicine called REZZAYO, which is designed to treat or prevent these infections. It's important to find effective and safe ways to help children who need this kind of treatment.
This is a 'Phase 1' study, which means it's one of the first times this medicine is being given to people, specifically children in this case. The main goal is to carefully watch how REZZAYO behaves in a child's body – how much medicine gets into the blood, how quickly it's used up, and how long it stays before being removed. This information is key to figuring out the right dose for children.
We will also be checking very closely for any side effects or uncomfortable feelings the children might have. By understanding both how the medicine works and if it's safe, doctors can learn whether it could be a good treatment option in the future. The medicine is given through a drip, which is a common way to give medicines directly into the bloodstream.
Key takeaways
- This study is testing a new medicine called REZZAYO for children with fungal infections.
- It's an early-stage study (Phase 1) focused on understanding how the medicine works in the body and if it's safe.
- Children from birth up to 17 years old can be considered.
- The medicine will be given through a drip, and a lot of tests will be done to monitor health.
- Families can withdraw from the study at any time.
Who may be eligible?
This study is looking for children and teenagers, from babies right up to 17 years old. Both boys and girls can take part. To be considered, a child would either be getting anti-fungal medicine to prevent a fungal infection, or they would have a suspected or confirmed fungal infection that needs treatment.
There will be specific medical checks to make sure that taking part is suitable and safe for each child. For instance, the doctors will make sure the child doesn't have other health conditions that might make the study risky for them. Only the study doctor can decide if a child can join.
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 child between birth and 17 years old?
- Does my child have a fungal infection, or are they taking anti-fungal medicine to prevent one?
- Is my child currently healthy enough to consider joining a study?
- Am I, as a parent or guardian, able to bring my child to study visits if they are eligible?
What does participation involve?
If a child joins this study, they will receive the study medicine, REZZAYO, through a drip into a vein. They will have regular blood tests to check how the medicine is working in their body. They will also have careful health checks to make sure they are feeling well and to look for any side effects. These checks include physical examinations, blood and urine tests, checking their heart with an ECG (a heart tracing), and monitoring their vital signs like temperature and blood pressure. We will continue to check on them for a period after the medicine is given to make sure they remain well. The exact number of visits and the total length of time they are involved will be explained fully by the study team.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is a fungal infection?
Fungal infections are caused by tiny living things called fungi and can affect different parts of the body. They can sometimes be serious, especially for people with weakened immune systems.
What is REZZAYO?
REZZAYO is the name of the new medicine being tested in this study. It's designed to fight fungal infections.
Why is this study for children?
It's important to understand how medicines work and if they are safe for children, as their bodies process medicines differently than adults.
What does 'Phase 1' mean?
'Phase 1' means it's an early study to mostly check how a new medicine behaves in the body and if it's safe, rather than how well it treats a condition yet.
Will my child get a placebo (dummy medicine)?
No, this study does not involve a placebo. All children in this study will receive the REZZAYO medicine.
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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