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A study on the use of vancomycin and a drug combination for treating infections in children through continuous antibiotic infusion.

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 study is being conducted to evaluate the effectiveness and safety of continuous antibiotic infusion in children with an Infection. An infection occurs when harmful germs, such as bacteria, enter the body and cause illness. The study focuses on comparing different ways of delivering medication to see which approach works best for treating these conditions.

The medications being studied include cloxacillin, benzylpenicillin, piperacillin, tazobactam, and vancomycin. These are types of antibiotics, which are medicines used to kill or stop the growth of bacteria. During the study, these drugs will be administered through an intravenous infusion, which is a method where the medicine is delivered directly into a vein through a tube to ensure it enters the bloodstream steadily.

The research involves a method called continuous infusion, meaning the medication is given at a constant rate over a 24-hour period rather than in separate doses. Participants will receive these treatments to help determine the best way to manage bacterial illnesses in a hospital setting.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in antibiotic treatment
You will receive a continuous antibiotic infusion, which means the medication is delivered into a vein through a tube over a 24-hour period.
The medication used may be cloxacillin (a total of 12 grams), benzylpenicillin (a total of 20,000,000 international units), piperacillin/tazobactam (a total of 12 grams), or vancomycin (a total of 3 grams).
These medications are administered via intravenous infusion, meaning they are put directly into the bloodstream.
Step 2
Monitoring and evaluation
The duration of the hospital stay, fever, and antibiotic treatment will be tracked.
The possibility of readmission to the hospital or a relapse, which is the return of the infection disease, will be monitored.

Who can join the trial?

8 criteria

The child must require treatment with intravenous (IV) antibiotics, which is medicine delivered directly into a vein through a tube.
The child must be clinically stable, meaning their medical condition is steady and not rapidly changing or worsening.
The child must not require staying in the hospital for their care.
A pump or cassette (the device used to deliver the medicine steadily) must be able to be changed at either the hospital or at home.
The people looking after the child must be able to contact the hospital if any help is needed.
The clinical diagnosis, which is the identification of the illness by a doctor, must be certain.
The child must not have any allergies, or harmful reactions, to the specific antibiotic being used.
The continuous antibiotic infusion, which is the process of giving medicine through a vein at a steady rate for a long time, must either not have started yet or must have started less than 24 hours before joining the study.

Who cannot join the trial?

4 criteria

The child cannot carry the infusion pump, which is a small medical device used to deliver medicine into the body at a steady rate.
The child is required to stay in the hospital for observation or for any other medical reason.
The diagnosis, which is the identification of the specific illness or condition the child has, is not clearly known.
The child has an infectious disease, which is an illness caused by germs like bacteria or viruses that can spread to others.

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Pirkanmaan hyvinvointialue
Verified
Tampere, Finland

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Investigated drugs

Cloxacillin
is an antibiotic medication given through a vein to help fight certain types of bacterial infections.
Benzylpenicillin
is an antibiotic medication given through a vein to treat various bacterial infections.
Piperacillin/Tazobactam
is a combination antibiotic medication given through a vein to treat serious bacterial infections.
Vancomycin
is an antibiotic medication given through a vein to treat severe infections caused by specific types of bacteria.

What is already known about the treatment

Cloxacillin
This medication is an antibiotic administered as a liquid through a vein via infusion. It is widely used in medicine to treat various bacterial infections, particularly those caused by specific types of bacteria like staphylococci. At a molecular level, it works by preventing bacteria from building their protective cell walls, which ultimately causes them cells to burst and die. It belongs to a group of drugs known as penicillinase-resistant penicillins.
Benzylpenicillin sodium
This antibiotic is given directly into a vein through a continuous liquid infusion. It is a well-established treatment used to fight a wide range of serious bacterial infections. The drug works by interfering with the process that bacteria use to create their outer protective layers, leading to their destruction. It is classified as a natural penicillin antibiotic.
Piperacillin/Tazobactam
This medicine is provided as a solution for infusion into a vein. It is a combination drug used to treat complex and severe bacterial infections that might otherwise resist treatment. Piperacillin works by attacking the bacteria's cell walls, while tazobactam protects the medicine by stopping certain enzymes that bacteria use to defend themselves. This combination is categorized as a penicillin antibiotic paired with an enzyme inhibitor.
Vancomycin hydrochloride
This medication is administered as a liquid through an intravenous infusion. It is a highly important antibiotic used to treat serious infections caused by certain resistant bacteria. It works at the molecular level by binding to the building blocks of the bacterial cell wall, preventing the bacteria from growing and multiplying. It belongs to a class of antibiotics known as glycopeptides.

Investigated diseases

Infectious disease - An infectious disease is a condition caused by harmful organisms such as bacteria, viruses, fungi, or parasites entering the body. These organisms can multiply within the host and interfere with normal bodily functions. The disease typically progresses as the pathogens spread through tissues or the bloodstream. As the infection develops, the body may react with symptoms like fever or inflammation. The severity and speed of progression often depend on the type of organism involved and the person's immune response.