Study on Teicoplanin Dosing for Patients with Sepsis: Comparing TDM-Optimized Dosing to Standard Care

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What is this study about?

This clinical trial is focused on studying the treatment of sepsis, a serious condition that occurs when the body’s response to an infection causes injury to its own tissues and organs. The treatment being investigated is a medication called Teicoplanin, which is used to fight bacterial infections. In this study, Teicoplanin is given as a powder that is mixed into a solution for injection or infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to compare two different ways of dosing Teicoplanin: one that is guided by a method called Therapeutic Drug Monitoring (TDM) and the other that follows the standard dosing practice. TDM is a technique used to measure the amount of drug in the blood at specific times to ensure the right dose is given. The study aims to see which method is more effective in reaching the desired drug levels in the body after five days of treatment.

Participants in the study will receive either the TDM-guided dosing or the standard dosing of Teicoplanin. The study will monitor how quickly the target drug levels are reached, the number of days participants spend in the hospital, and any occurrences of treatment failure or kidney issues during the treatment. The study will help determine if the TDM-guided dosing offers any advantages over the standard dosing in treating sepsis.

1 joining the study

Upon joining the study, the patient or a representative must sign the Informed Consent Form. This confirms understanding and agreement to participate in the trial.

2 initial treatment

The patient will begin treatment with Teicoplanin Hikma 400 mg, which is a powder that is mixed to form a solution for injection or infusion. This medication is administered through a vein, a process known as intravenous administration.

3 treatment monitoring

The study aims to compare two dosing methods: TDM-optimized dosing and standard dosing. TDM stands for therapeutic drug monitoring, which involves adjusting the dose based on drug levels in the blood.

The main goal is to assess the effectiveness of these dosing methods in achieving the desired drug concentration in the body by day 5 of treatment.

4 ongoing assessment

Throughout the trial, the patient’s response to the medication will be closely monitored. This includes checking for any side effects and measuring how well the drug is working.

The study will also track the time it takes to reach the target drug concentration, the occurrence of any clinical failures by day 30, the total number of days spent in the hospital, and any incidence of acute kidney injury during treatment.

5 completion of trial

The trial is expected to continue until the end of 2024. The patient’s participation will contribute to understanding the best dosing strategy for teicoplanin in treating sepsis.

Who Can Join the Study?

The patient is admitted to the ICU (Intensive Care Unit), haematology, MDL, or orthopaedics department.
The patient is at least 18 years old on the day of inclusion.
The patient is treated with teicoplanin as part of standard care. (Teicoplanin is a type of antibiotic medication.)
The patient or a representative is willing to sign the Informed Consent Form. (This is a document that explains the study and confirms that the patient agrees to participate.)

Who Cannot Join the Study?

Patients with a known allergy to the study medication.
Patients who are pregnant or breastfeeding.
Patients with severe liver disease. The liver is an organ that helps process medications.
Patients with severe kidney disease. The kidneys help filter waste from the blood.
Patients currently participating in another clinical trial.
Patients who have had a major surgery within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients with a mental health condition that might affect their ability to follow study instructions.
Patients who are unable to provide informed consent. This means they cannot understand the study and agree to participate.

Where you can join this trial?

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Site Name	City	Country	Status
Srjgbtkgx Rafpjkw Uhblobvgwb Mxnsoti Cxaucy	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

Teicoplanin

Teicoplanin is an antibiotic used to treat serious infections caused by bacteria. In this clinical trial, the researchers are comparing two ways of giving teicoplanin to patients. One group of patients will receive teicoplanin in a standard way, which means they will get a fixed amount of the medication. The other group will receive teicoplanin in a way that is adjusted based on regular blood tests. These tests help doctors decide the right amount of medication for each patient, aiming to make the treatment more effective and reduce side effects. This method is called TDM-guided dosing, where TDM stands for Therapeutic Drug Monitoring.

Investigated diseases:

Sepsis

Sepsis – Sepsis is a severe and widespread response of the body to an infection, leading to inflammation throughout the body. It begins when the immune system releases chemicals into the bloodstream to fight an infection, causing widespread inflammation. This inflammation can lead to blood clots and leaky blood vessels, impairing blood flow and depriving organs of nutrients and oxygen. As sepsis progresses, it can cause organ dysfunction, where organs such as the heart, lungs, and kidneys may not function properly. If not managed, it can lead to septic shock, characterized by a significant drop in blood pressure. The progression of sepsis can vary, but it typically requires prompt medical attention to prevent further complications.

Trial ID:

2023-503411-15-00

Protocol code:

113998

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Teicoplanin Dosing for Patients with Sepsis: Comparing TDM-Optimized Dosing to Standard Care

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?