Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A randomized trial investigating the superiority of TDM-optimized teicoplanin dosing versus standard of care

This research study is investigating a medicine called teicoplanin, which is used to treat a severe type of infection known as sepsis. The main goal is to compare two ways of giving this medicine to patients. One way is the standard method, and the other involves adjusting the dose of teicoplanin individually for each patient to make sure they get the right amount. We want to see if this individualised dosing helps the medicine reach its most effective level in the body more quickly and whether it leads to better recovery and fewer side effects like kidney problems. The study includes adults aged 18 and over, of any sex.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

Start

01 Jun 2023

Sepsis

What is this study about?

This study is looking into a medicine called teicoplanin, which is often used to treat very serious infections, especially when someone has sepsis. Sepsis is a life-threatening condition where the body's response to an infection damages its own tissues and organs. Teicoplanin is an important treatment for this.

At the moment, teicoplanin is usually given in a standard way. However, we know that people's bodies can react differently to medicines, meaning that a standard dose might not be perfect for everyone. This study wants to see if adjusting the dose of teicoplanin for each patient, based on how their body absorbs and uses the medicine, can make it work even better.

Our main focus is to see if this personalised dosing method helps the medicine reach the right level in the body to fight the infection more effectively and quickly. We'll also be looking at whether patients recover better, spend less time in hospital, and experience fewer side effects, such as problems with their kidneys. By finding the best way to give this medicine, we hope to improve care for people with sepsis.

Key takeaways

This study evaluates adjusting antibiotic doses for sepsis patients.
It aims to find the best way to give teicoplanin for serious infections.
Compares standard dosing with personalised dosing based on blood tests.
Hopes to improve recovery and reduce side effects like kidney issues.
Open to adults aged 18 and over who have sepsis.

Who may be eligible?

This study is looking for adults who have a serious infection called sepsis and need treatment with the medicine teicoplanin. You must be at least 18 years old, and the study is open to both men and women.

The research team will check other specific health details to make sure the study is a good fit for you and that it's safe for you to take part. This will involve reviewing your medical history and current health condition to ensure you meet all the necessary requirements for the study.

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?
Do you have a serious infection called sepsis?
Are you currently being treated, or will you be treated, with the medicine teicoplanin?
Are you of any sex (male or female)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the medicine teicoplanin, just as you would normally receive for your sepsis. The main difference is that some people will have their teicoplanin dose carefully adjusted based on special tests to see how much medicine is in their body. These tests involve taking small blood samples. Other people will receive the standard dose of teicoplanin.

The research team will closely monitor your health throughout your hospital stay. They will check how well the medicine is working and look for any side effects. You'll likely have regular blood tests and medical assessments, which are part of your usual care but will also provide important information for the study. The study looks at what happens in the first 5 days of treatment and then tracks your progress up to 30 days after starting treatment, including how long you stay in hospital.

Potential risks and benefits

Taking part in this study may offer a potential benefit if the personalised dosing of teicoplanin proves to be more effective, helping the medicine work better and faster against your infection. This could lead to a better recovery and potentially fewer side effects. However, as with any medical treatment, there's always a possibility of risks or side effects from the medicine itself, regardless of how it's given. The study team will carefully monitor you for any problems. You are free to withdraw from the study at any time, for any reason, 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.

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Unverified
Netherlands

Common questions

What is sepsis?

Sepsis is a very serious and life-threatening reaction to an infection. It happens when the body's own immune system overreacts, damaging its own organs and tissues.

What is teicoplanin?

Teicoplanin is a type of antibiotic medicine used to treat serious bacterial infections, including those that can cause sepsis.

What does 'TDM-optimized dosing' mean?

It means the dose of teicoplanin is adjusted specifically for you, based on special blood tests that measure the amount of medicine in your body. This helps ensure you get the right amount for the best effect.

Will I know if I'm getting the standard dose or the special adjusted dose?

Because this is a research study, participants are randomly assigned to one group or the other, and often neither you nor your doctor will know which group you are in during the study, to keep the results fair and unbiased.

How long will I be involved in the study?

The main part of the study looks at how the medicine works in the first 5 days, but your progress will be followed up to 30 days after you start treatment with teicoplanin.