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Study on Antibiotics Amoxicillin, Clavulanic Acid, Ciprofloxacin, and Drug Combination for Children with Malignant Brain Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on children with malignant brain tumors, which are aggressive growths in the brain that can spread to other areas. The study aims to understand how different antibiotics behave in the body, specifically in the cerebrospinal fluid (CSF)amoxicillin, clavulanic acid, ciprofloxacin, sulfamethoxazole, trimethoprim, cefotaxime sodium, fosfomycin, cefuroxime sodium, ceftriaxone sodium, linezolid, vancomycin, meropenem anhydrous, and gentamicin. These medications are used to treat infections and are administered either orally or through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to measure the levels of these antibiotics in the CSF and blood plasma after they are administered to children with brain tumors that have spread or are at risk of spreading to the lining of the brain and spinal cord. This will help researchers understand how well these antibiotics can reach the CSF and potentially treat infections in this area. The study will involve regular monitoring of antibiotic levels in the body over a period of time to gather data on how the drugs are distributed and how long they stay active in the CSF.

Participants in the study will receive either the antibiotics or a placebo, and their progress will be closely monitored by medical professionals. The study is designed to provide valuable information that could improve the treatment of infections in children with brain tumors, helping to ensure that the antibiotics used are effective in reaching the areas where they are needed most. This research is important for developing better treatment strategies for managing infections in children with these serious conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide a written informed consent. This consent confirms your understanding and agreement to participate in the clinical trial.
You must be between the ages of 0 and 18 years and have a central nervous system tumor with a risk of spreading to the membranes surrounding the brain and spinal cord.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status and ongoing treatments. This includes reviewing any current antibiotic treatments you are receiving either orally or through intravenous infusion.
Your life expectancy should be at least 8 weeks to participate in the study.
Step 3
Medication administration
During the trial, you will receive different antibiotics either orally or through intravenous infusion. The antibiotics include amoxicillin with clavulanic acid, ciprofloxacin, sulfamethoxazole with trimethoprim, cefotaxime sodium, fosfomycin, cefuroxime sodium, ceftriaxone sodium, linezolid, vancomycin, meropenem anhydrous, and gentamicin.
The specific dosage, frequency, and duration of each medication will be determined based on your individual treatment plan and medical needs.
Step 4
Monitoring and data collection
Throughout the trial, regular monitoring will be conducted to measure the concentration of antibiotics in your cerebrospinal fluid and blood plasma.
This monitoring helps to understand how the antibiotics are distributed in your body and their effectiveness in treating the infection.
Step 5
Completion of the trial
Upon completion of the trial, a final assessment will be conducted to evaluate the outcomes of the treatment and any changes in your health status.
The data collected during the trial will contribute to understanding the pharmacokinetics of antibiotics in children with brain tumors.

Who can join the trial?

6 criteria

Written informed consent from the patient and/or their parents is required. This means that you and your parents need to agree to participate after understanding the study details.
Participants can be female or male, aged between 0 and 18 years at the time of their initial diagnosis.
Participants must have a CNS tumor with leptomeningeal dissemination or be at risk of it. CNS stands for the central nervous system, which includes the brain and spinal cord. Leptomeningeal dissemination means the spread of cancer to the membranes covering the brain and spinal cord.
Participants must be receiving ongoing treatment with intravenous (through a vein) or oral (by mouth) antibiotics for therapeutic reasons.
Participants must be receiving ongoing treatment with chemotherapy administered intrathecally (directly into the spinal fluid) via an Ommaya reservoir for therapeutic reasons. An Ommaya reservoir is a device placed under the scalp used to deliver medication directly to the brain or spinal fluid.
Participants must have a life expectancy of at least 8 weeks.

Who cannot join the trial?

5 criteria

Patients who do not have a malignant brain tumor cannot participate. A malignant brain tumor is a type of cancer that occurs in the brain.
Patients who do not have leptomeningeal dissemination or are not at risk of it cannot participate. Leptomeningeal dissemination is when cancer spreads to the membranes covering the brain and spinal cord.
Patients who are not within the specified age range cannot participate. The study is for children.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are considered part of a vulnerable population are not excluded from this study.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Antibiotics are medicines used to fight infections caused by bacteria. In this clinical trial, different antibiotics are being studied to see how they move through the body, especially in the cerebrospinal fluid and blood, of children with malignant brain tumors. The goal is to understand how these antibiotics can help treat or prevent infections in these children, who may have cancer that has spread to the lining of the brain or are at risk of such spread. The antibiotics can be given either through a vein (intravenously) or by mouth (orally), and the study aims to measure their levels in the body to ensure they are effective and safe for the patients.

What is already known about the treatment

Antibiotics – Antibiotics in this study are administered either intravenously, which means directly into the bloodstream through a vein, or orally, which means taken by mouth. Currently, these antibiotics are being studied for their effectiveness in treating children with malignant brain tumors, particularly focusing on their ability to reach the cerebrospinal fluid, which surrounds the brain and spinal cord. The main goal is to understand how well these antibiotics can penetrate this fluid to potentially treat or prevent the spread of cancer cells in the brain. Antibiotics work by targeting and killing bacteria or stopping their growth, but in this context, they are being explored for their potential role in cancer treatment. They are classified as antimicrobial agents, which are substances used to treat infections caused by microorganisms.

Investigated diseases

Brain Tumors – Brain tumors are abnormal growths of cells within the brain. They can be either benign, meaning non-cancerous, or malignant, meaning cancerous. These tumors can originate in the brain itself or spread from other parts of the body. As they grow, they can disrupt normal brain function by pressing on or invading nearby tissues. Symptoms often depend on the tumor's size, type, and location, and may include headaches, seizures, or changes in behavior. The progression of brain tumors varies widely, with some growing slowly over time and others advancing more rapidly.