Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Vancomycin treatment in critically ill adults using model-informed precision dosing tool – prospective low-intervention clinical trial. (ProVanc)

The ProVanc study is testing a new way to give an antibiotic called vancomycin to very unwell adults with serious infections. Doctors often use vancomycin when other treatments aren't suitable. This study uses a special computer tool to help doctors work out the perfect dose of vancomycin for each patient. The main aim is to see if, with this tool, patients spend more time getting the ideal amount of the medicine in their system. Giving the right dose helps the medicine work best and reduces the risk of side effects. The study will also look at how long patients stay in hospital, if their infection gets better, and any problems like kidney issues.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Tartu University Hospital

Enrolment target

Start

12 Jan 2024

Serious infections where according to the treating physician's decision treatment with intravenous vancomycin is needed.

What is this study about?

Imagine you're really unwell with a serious infection, and your doctor prescribes an important antibiotic called vancomycin. For this medicine to work its best, it needs to be at just the right level in your body – not too little, so it can fight the infection properly, and not too much, to avoid unwanted side effects. Finding this perfect balance can be tricky for doctors.

That's where the ProVanc study comes in. Researchers have developed a clever computer tool, almost like a super-smart calculator, to help doctors work out the ideal vancomycin dose for each patient. This study is testing if using this tool means patients get closer to that 'just right' level of medicine for longer periods. It's about personalising the treatment to make it as effective and safe as possible.

We'll be looking at several things, like how well patients recover, how long they need to stay in hospital, and if there are any issues with their kidneys, which can sometimes be affected by antibiotics. Ultimately, the goal is to improve how we treat serious infections, making sure patients get the best possible care with vancomycin.

Key takeaways

Tests a new computer tool to help doctors give the right dose of vancomycin.
Aims to make vancomycin treatment more effective and safer for seriously ill adults.
Involves patients already receiving vancomycin for serious infections.
Focuses on personalised dosing to reach ideal medicine levels.
Monitors infection improvement, hospital stay, and potential side effects.
Participation will not change your standard medical care, just how your dose is guided.

Who may be eligible?

This study is designed for adults aged 18 or over. It includes people who are seriously ill and whose doctor has decided that they need to be treated with vancomycin, an antibiotic given directly into their bloodstream.

There aren't any specific restrictions based on your gender. The most important factor is that a doctor treating you believes vancomycin is the correct medication for your serious infection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you seriously ill?
Has your doctor decided you need treatment with intravenous vancomycin for a serious infection?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive vancomycin as part of your normal treatment, as decided by your doctor for your serious infection. The main difference would be that your doctors would use a special computer tool to help them choose the best dose for you. This means they might adjust your vancomycin dose based on the information from this tool.

Throughout your treatment, your medical team would regularly check your vancomycin levels through blood tests, just like they normally would for this type of medication. Researchers would collect information about your health, how long you stay in hospital, and how your infection responds to the treatment. This will all be part of your routine care, with no extra visits specifically for the study. The study looks at your journey while you're receiving vancomycin and until you leave the intensive care unit or hospital.

Potential risks and benefits

Taking part in this study could potentially benefit you by ensuring your vancomycin dose is as accurate as possible, which might help the medicine work better and reduce side effects. However, there's no guarantee this will be the case for every individual. All medical treatments carry some risks, and vancomycin itself has known side effects, such as potential kidney issues, which your doctors will monitor closely regardless of the study. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Estonia

Common questions

What is vancomycin?

Vancomycin is a powerful antibiotic used to treat serious bacterial infections, especially when other antibiotics might not work or aren't suitable.

What does 'model-informed precision dosing' mean?

It means using a computer programme or 'model' to help doctors calculate the most precise and effective dose of medication for each individual patient, based on their specific needs.

Will I get different care if I join the study?

You will receive the same high standard of care for your infection. The difference is that your doctors will use a special computer tool to guide their decisions about your vancomycin dose, aiming for the best possible treatment.

What is an 'AUC' measurement?

AUC stands for 'Area Under the Curve' and it’s a way doctors measure how much medicine is in your body over a period of time. For vancomycin, it helps to know if enough of the drug is at work.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can decide to stop participating in the study at any time, and this will not affect the medical care you receive.