Phase 1, Open-Label, single arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants from 2 to less than 12 years of age with a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis with Antibiotics
This study is looking into a new oral medicine called gepotidacin for children between 2 and under 12 years old. This medicine might help treat bacterial infections, such as urine infections, or be used to prevent them. The main purpose of this study is to understand how gepotidacin moves through a child's body and how their body handles it. We'll be looking at things like how much of the medicine gets into their blood, how long it stays there, and how it's cleared out. Importantly, we'll also be checking carefully for any side effects to make sure the medicine is safe. Children in the study will also receive the standard care they would normally get for their infection or prevention.
At a glance
What is this study about?
This research study is about a new medicine called gepotidacin, which is taken by mouth. We want to learn more about how this medicine works in children aged 2 to under 12 years old. Specifically, we're interested in how their bodies process the medicine, including how much of it gets into their system, how long it stays there, and how quickly their body gets rid of it. This information is really important for doctors to know the right amount of medicine to give to children.
The study also has a very important goal of checking for any side effects. Making sure a new medicine is safe for children is our top priority. We will be carefully monitoring their health throughout the study. Children participating in this study will still receive the usual care for their bacterial infection, such as a urine infection, or while they are taking antibiotics to prevent an infection.
By gathering this information, researchers can better understand how gepotidacin might be used safely and effectively in younger patients in the future. Studies like this help to develop new and better treatments for children.
Key takeaways
- This study is testing a new medicine (gepotidacin) for children.
- It's for children aged 2 to under 12 with bacterial infections, like urine infections.
- The main goals are to see how the medicine works in the body and if it's safe.
- Participants will also receive their usual medical care.
- It's an important early step in developing new treatments for children.
Who may be eligible?
This study is looking for children between 2 and under 12 years of age. They need to have a suspected or confirmed bacterial infection, like a urine infection. Alternatively, they might be taking antibiotics to prevent an infection from happening.
Because this is a very early study (a 'Phase 1' study), there aren't many detailed restrictions on who can join, other than the age and infection status. The main goal is to understand how the medicine behaves in the body in this specific age group.
More specific details about health conditions that might prevent a child from joining would be discussed by the study doctor to ensure their safety.
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 your child between 2 and under 12 years old?
- Does your child have a suspected or confirmed bacterial infection?
- Or is your child taking antibiotics to prevent an infection?
- Is your child able to take medicine by mouth?
What does participation involve?
If your child takes part in this study, they will receive a single dose of the study medicine, gepotidacin, by mouth. This will be given in addition to any other antibiotics or care they are already receiving from their doctor for their infection or prevention. Over a short period, we will take several blood samples to measure how much of the gepotidacin is in their system. We'll also monitor their vital signs like temperature, blood pressure, and pulse rate, and perform an electrocardiogram (ECG) to check their heart.
Throughout the study, we will carefully record any side effects or changes in your child's health. The study involves a few visits to the clinic for these checks, blood samples, and observations. The total duration of active participation for your child will be relatively short, focusing on the period after they receive the single dose of medicine.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is gepotidacin?
Gepotidacin is a new medicine being tested to treat or prevent bacterial infections.
Which children can join this study?
Children aged 2 to under 12 who have a bacterial infection or are taking antibiotics to prevent one can join.
What kind of infections are being studied?
The study focuses on bacterial infections, such as urinary tract infections.
Will my child still get their usual medicine?
Yes, your child will continue to receive their standard medical care and other antibiotics if needed.
What does a 'Phase 1' study mean?
A Phase 1 study is a very early stage of research, mainly focused on understanding how a new medicine works in the body and if it's safe.
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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