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Study on Vancomycin Hydrochloride for Treating Serious Infections in Critically Ill Adults Using a Precision Dosing Tool

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 is focused on treating serious infections in critically ill adults using a medication called vancomycin hydrochloride. These infections are severe enough that a doctor has decided that treatment with intravenous vancomycin is necessary. The study aims to evaluate a new tool that helps doctors determine the best dose of vancomycin to ensure patients receive the right amount of the drug during their treatment.

Participants in the study will receive vancomycin through an infusion, which means the medication is delivered directly into the bloodstream. The study will use a special tool to help doctors adjust the dose of vancomycin to keep it within a target range for most of the treatment period. This approach is intended to improve the effectiveness of the treatment and reduce the risk of side effects.

The study will monitor how well patients stay within the desired range of vancomycin levels in their blood. It will also look at other factors, such as how long patients stay in the hospital, their overall recovery, and any potential side effects like kidney problems. The goal is to find the best way to use vancomycin to treat serious infections in critically ill patients effectively and safely.

The research process

The trial runs in 6 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 assessed to ensure you meet the criteria for participation. This includes being at least 18 years old, being admitted to the tertiary intensive care unit, and having a medical need for intravenous vancomycin treatment as determined by your doctor.
Step 2
Beginning treatment
Your treatment will start with the administration of vancomycin hydrochloride through an infusion. This means the medication will be delivered directly into your bloodstream via a drip. The dosage and frequency will be determined using a special tool designed to help achieve the best possible results.
Step 3
Monitoring and adjustments
Throughout the treatment, your response to vancomycin will be closely monitored. The goal is to maintain the medication within a specific target range for at least 70% of the treatment time. Adjustments to your dosage may be made based on these observations to ensure the best outcome.
Step 4
Evaluation of treatment
Your progress will be evaluated regularly to determine if the treatment goals are being met. This includes checking if the medication levels are within the desired range during the first 24 to 48 hours and throughout the treatment period.
Step 5
Completion of treatment
The length of your vancomycin treatment will depend on your individual response and medical condition. Upon completion, your overall health and recovery will be assessed, including whether you have achieved a clinical cure without needing additional antibiotics.
Step 6
End of study evaluation
At the end of the study, your health status will be reviewed. This includes checking for any side effects, such as kidney issues, and determining your condition at discharge, whether you are going home, staying in the hospital, or moving to another ward.

Who can join the trial?

3 criteria

Must be at least 18 years old.
Must be admitted to a tertiary intensive care unit. This is a specialized hospital unit for patients who need intensive medical care.
Must have a medical condition that requires treatment with intravenous vancomycin. This means the patient needs to receive the medication vancomycin directly into their veins, as decided by their doctor.

Who cannot join the trial?

1 criterion

Patients with **serious infections** that require treatment with **intravenous vancomycin** cannot participate. Intravenous means the medicine is given directly into a vein.

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Verified sites

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Verified
Tartu University Hospital
Tartu, Estonia

Trial locations

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Investigated drugs

Vancomycin is an antibiotic used to treat serious infections caused by bacteria. In this clinical trial, the focus is on using a special tool to help doctors give the right amount of vancomycin to patients who are very sick. The goal is to make sure that the medicine is working well for more than 70% of the time during treatment. This tool helps doctors decide the best dose for each patient, so they can get the most benefit from the medication while reducing the risk of side effects.

Vancomycin Hydrochloride

What is already known about the treatment

Vancomycin – Vancomycin is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently used in medicine to treat serious infections, especially in critically ill patients, where the treating physician decides that intravenous vancomycin is necessary. The main therapeutic use of vancomycin is to combat severe bacterial infections, particularly those caused by bacteria resistant to other antibiotics. At the molecular level, vancomycin works by inhibiting the formation of bacterial cell walls, which are essential for bacteria to survive and multiply. It belongs to the pharmacological class of glycopeptide antibiotics, which are known for their ability to treat serious infections caused by Gram-positive bacteria.

Investigated diseases

Serious infections – Serious infections are conditions caused by harmful microorganisms such as bacteria, viruses, fungi, or parasites that invade the body and multiply. These infections can affect various parts of the body, including the lungs, bloodstream, or tissues, leading to significant illness. The progression of serious infections depends on the type of microorganism and the body's response. Initially, symptoms may include fever, fatigue, and localized pain or swelling. If untreated, the infection can spread, causing more severe symptoms and potentially affecting multiple organ systems. The body's immune response plays a crucial role in controlling and resolving the infection.