Study on How Antibiotics Work in the Spinal Fluid of Children with Brain Drains: Cefuroxime, Vancomycin, and Gentamicin with a Drug Combination

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What is this study about?

This clinical trial is focused on understanding how certain antibiotics behave in the cerebrospinal fluid (CSF) of children who have an external ventricular drain. An external ventricular drain is a medical device used to relieve pressure on the brain caused by fluid accumulation. The study involves several antibiotics, including cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam, and cefazolin. These medications are commonly used to treat or prevent bacterial infections.

The purpose of the study is to determine how these antibiotics move and are processed in the CSF of children with an external ventricular drain. This involves measuring the concentration of the antibiotics in the CSF over time. The study will help to understand the best ways to use these antibiotics in young patients who need them for treating infections or preventing them.

Participants in the study will receive one of the antibiotics mentioned above, or a placebo, through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the levels of the antibiotics in the CSF to gather important information about their effectiveness and safety in this specific group of patients. This research is important for improving treatment strategies for children with infections who have an external ventricular drain.

1 joining the study

The study involves children aged between 3 days and 3 months, or 7 days and 3 months, depending on the group.

The child must have an external ventricular drain and be hospitalized in an intensive or intermediate care unit.

A clinical diagnosis of infection requiring antibiotic therapy or prophylaxis is necessary.

Consent must be signed by at least one parent or legal representative.

2 medication administration

The child will receive antibiotics as part of their treatment or infection prevention.

Medications include linezolid, vancomycin, cefuroxime sodium, cefazolin, piperacillin sodium with tazobactam sodium, gentamicin, and ampicillin sodium.

All medications are administered through an intravenous infusion, which means they are given directly into a vein.

3 monitoring and data collection

The study aims to understand how these antibiotics behave in the cerebrospinal fluid (CSF) of children.

Key measurements include the maximum concentration of the drug in the CSF, the time it takes to reach this concentration, the area under the concentration-time curve, and the half-life of the drug in the CSF.

4 completion of the study

The study is expected to continue until February 1, 2028.

Throughout the study, the child’s health and response to the medication will be closely monitored.

Who Can Join the Study?

The child can be a girl or a boy, aged between 3 days and 3 months for certain study groups.
The child can be a girl or a boy, aged between 7 days and 3 months for other study groups.
The child must have an external ventricular drain in place. This is a tube used to relieve pressure in the brain.
The child must be in the hospital, either in an intensive care unit or an intermediate care unit.
The child must have a clinical diagnosis of an infection that requires treatment with antibiotics, or be receiving antibiotics to prevent an infection.
The child must be currently receiving or have planned treatment with specific antibiotics such as cefuroxime, gentamicin, vancomycin, ampicillin, linezolid, piperacillin/tazobactam, or cefazolin. These are used to treat or prevent bacterial infections.
At least one parent or legal representative must sign a consent form agreeing to the child’s participation in the study.

Who Cannot Join the Study?

Patients who do not have an external ventricular drain. An external ventricular drain is a medical device used to relieve pressure in the brain by draining excess fluid.
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	04.10.2018

Trial locations

Investigated drugs:

Cefuroxime is an antibiotic used to treat a variety of bacterial infections. In this trial, it is being studied to understand how it moves through the cerebrospinal fluid in children with an external ventricular drain.

Vancomycin is an antibiotic that is often used to treat serious infections caused by bacteria that are resistant to other antibiotics. The trial aims to study its behavior in the cerebrospinal fluid of children with an external ventricular drain.

Gentamicin is an antibiotic used to treat several types of bacterial infections, particularly those caused by Gram-negative bacteria. This trial is examining how gentamicin is processed in the cerebrospinal fluid of children with an external ventricular drain.

Ampicillin is a penicillin-type antibiotic that is used to treat a wide range of bacterial infections. The study is focused on understanding its pharmacokinetics in the cerebrospinal fluid of children with an external ventricular drain.

Linezolid is an antibiotic used to treat infections caused by Gram-positive bacteria, including those resistant to other antibiotics. The trial is investigating how linezolid behaves in the cerebrospinal fluid of children with an external ventricular drain.

Piperacillin/Tazobactam is a combination antibiotic used to treat a variety of infections, including those caused by resistant bacteria. This study is looking at how this combination is processed in the cerebrospinal fluid of children with an external ventricular drain.

Cefazolin is an antibiotic used to treat bacterial infections, particularly those caused by Gram-positive bacteria. The trial is studying its pharmacokinetics in the cerebrospinal fluid of children with an external ventricular drain.

External Ventricular Drain – An external ventricular drain (EVD) is a medical device used to relieve elevated intracranial pressure and drain cerebrospinal fluid (CSF) from the brain’s ventricles. It is often used in patients with conditions such as hydrocephalus, traumatic brain injury, or brain hemorrhage. The device consists of a catheter inserted into the ventricles and connected to an external drainage system. Over time, the EVD helps manage fluid buildup and pressure within the skull. The progression of conditions requiring an EVD can vary, but the device itself is a temporary measure to stabilize the patient. Regular monitoring and adjustments are necessary to ensure proper function and prevent complications.

Trial ID:

2024-515791-12-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on How Antibiotics Work in the Spinal Fluid of Children with Brain Drains: Cefuroxime, Vancomycin, and Gentamicin with a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?