Medical University Of Vienna
Vienna, Austria
Not recruitingVentricular drainage
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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- 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 trial?
4 criteria
- 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.
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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.
What is already known about the treatment
Cefuroxime
Cefuroxime is administered intravenously and is currently used in medical practice to treat bacterial infections. It is well-documented in medical literature as an effective antibiotic. The main therapeutic indication for cefuroxime is the treatment of infections caused by susceptible bacteria. It works by inhibiting bacterial cell wall synthesis, leading to the death of the bacteria. Cefuroxime belongs to the pharmacological class of cephalosporin antibiotics.
Vancomycin
Vancomycin is administered intravenously and is widely used in medicine to treat serious bacterial infections. It is recognized in medical literature for its effectiveness against Gram-positive bacteria. The primary therapeutic indication is for infections caused by resistant bacteria, such as MRSA. Vancomycin works by inhibiting cell wall synthesis in bacteria, which results in bacterial cell death. It is classified as a glycopeptide antibiotic.
Gentamicin
Gentamicin is administered intravenously and is commonly used in medical settings to treat severe bacterial infections. It is well-established in medical literature for its efficacy against Gram-negative bacteria. The main therapeutic indication is for serious infections like sepsis. Gentamicin works by binding to bacterial ribosomes, disrupting protein synthesis, and causing bacterial cell death. It belongs to the aminoglycoside class of antibiotics.
Ampicillin
Ampicillin is administered intravenously and is a well-known antibiotic in medical practice for treating various bacterial infections. It is documented in medical literature for its broad-spectrum activity. The primary therapeutic indication is for infections caused by susceptible bacteria. Ampicillin works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It is classified as a penicillin antibiotic.
Linezolid
Linezolid is administered intravenously and is used in medicine to treat infections caused by resistant bacteria. It is recognized in medical literature for its effectiveness against Gram-positive bacteria, including MRSA. The main therapeutic indication is for serious infections like pneumonia. Linezolid works by inhibiting bacterial protein synthesis, which prevents bacterial growth. It belongs to the oxazolidinone class of antibiotics.
Piperacillin/Tazobactam
Piperacillin/Tazobactam is administered intravenously and is widely used in medical practice to treat a variety of bacterial infections. It is well-documented in medical literature for its broad-spectrum activity. The primary therapeutic indication is for severe infections, including those caused by resistant bacteria. Piperacillin works by inhibiting bacterial cell wall synthesis, while tazobactam inhibits beta-lactamase enzymes, enhancing piperacillin's effectiveness. It is classified as a combination penicillin antibiotic.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2024-515791-12-00Estimated enrolment56 patientsSponsorMedical University Of Vienna
sourced from the EU Clinical Trials Register and site verification
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