Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Pharmacokinetics of antibiotics in cerebrospinal fluid of children with external ventricular drain

This research study is for children who have a special tube called an external ventricular drain, which is used to help drain fluid from around the brain. Doctors want to understand exactly how several common antibiotics travel into the brain's fluid (called cerebrospinal fluid) and how long they stay effective there. By studying different antibiotics like Linezolid, Vancomycin, Cefuroxime, and others, researchers hope to find the best ways to treat infections in children with these drains. This is an early-stage study, meaning it's focused on understanding how the medicines work in the body rather than testing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Medical University Of Vienna

Enrolment target

Start

08 Sep 2024

patients with external ventricular drain

What is this study about?

Imagine your child has a special tube, called an external ventricular drain, to help manage fluid around their brain. If your child gets an infection, doctors need to give them antibiotics to fight it. But it's really important for the doctors to know that enough of the antibiotic actually gets into the fluid around the brain to kill the infection. Because children's bodies are still growing and developing, medicines can work differently than in adults.

This study, which is an early stage of human research (often called Phase I), is designed to carefully look at how several different, common antibiotics behave in the bodies of children with these drains. Researchers aren't testing a new, unproven drug, but rather studying how well existing, well-known antibiotics reach the area where they are needed most in these specific patients.

The main goal is to measure how much of each antibiotic reaches the brain fluid, how quickly it gets there, and how long it stays at a helpful level. This information is crucial for doctors to make sure children get the right dose of medication to effectively fight serious infections and get better.

Key takeaways

This study helps doctors understand common antibiotics in children.
It focuses on children with a special tube called an external ventricular drain.
Examines how much antibiotic reaches brain fluid and how long it stays.
Uses standard, approved antibiotics, not new experimental drugs.
Aims to improve future treatment for infections in these children.
Involves extra, small fluid samples during routine care.

Who may be eligible?

This study is particularly for children who have an external ventricular drain. This is a special tube that helps drain fluid from around the brain, usually placed during or after surgery, often for conditions that cause fluid buildup.

There are no specific age limits mentioned, meaning children of any age who have this type of drain might be able to take part. Both boys and girls can join the 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.

Does your child have an external ventricular drain?
Is your child receiving one of the listed antibiotics for an infection?
Are you comfortable with extra fluid samples being taken from the drain?
Are you happy for your child to take part in research that helps others?

Answer every question to see your result.

What does participation involve?

If your child takes part, doctors will give them one of the specific antibiotics listed (such as Linezolid, Vancomycin, or others) as part of their standard treatment. The main thing you'll notice that's different is that the study team will take small, extra samples of your child's brain fluid from their external ventricular drain at certain times after the antibiotic is given. This is usually done at the same time as any usual samples needed for their care, whenever possible. The samples are then tested to see how much of the antibiotic is present. There are no extra hospital visits required beyond their normal care, and the study duration will depend on how long your child is receiving the antibiotic and has the drain in place.

Potential risks and benefits

The potential benefit of taking part is that the information gathered will help doctors better understand how to treat infections in children with external ventricular drains in the future, improving care for many children. The risks are generally low, as the antibiotics used are standard treatments. The main extra procedure is taking small fluid samples, which might cause some minor discomfort or very small risks associated with any medical sampling. You and your child have the right to withdraw from the study at any time without it affecting your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is an external ventricular drain?

It's a small, temporary tube placed in the brain to help drain excess fluid, often after surgery or to manage certain conditions.

Are the antibiotics new or experimental?

No, the antibiotics used in this study are well-known and commonly used to treat infections. The study is learning how they work in a specific group of children.

Will my child get a different type of antibiotic if we join?

Your child will receive one of the listed antibiotics as part of their regular care, chosen by their doctor based on their needs. The study simply observes how that medicine works.

How often will fluid samples be taken?

Small fluid samples will be taken from the drain at specific times, often coinciding with when samples are already needed for your child's usual medical care.

Does this study involve healthy children?

No, this study is only for children who are already unwell and have an external ventricular drain as part of their medical treatment.