Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Pharmacokinetic study of colistimethate sodium

This study is investigating a medicine called colistimethate sodium, which is used to treat serious infections caused by certain types of germs that don't respond well to other treatments. Researchers want to understand how this medicine moves through the body, how it's used, and how it's removed. This type of study, called a 'Pharmacokinetic' study, helps doctors figure out the best and safest dose of a medicine to give. It's for adult patients who have these difficult-to-treat infections and haven't had success with other options. By studying this, doctors hope to improve how these serious infections are treated in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Tarchominskie Zaklady Farmaceutyczne Polfa S.A.

Enrolment target

Start

24 Apr 2025

serious infections caused by selected aerobic gram-negative pathogens in patients with limited treatment options

What is this study about?

Imagine you have a very serious infection, and the usual medicines aren't working well. Doctors are always looking for better ways to fight these tough infections. This study is about a particular medicine called colistimethate sodium. It's an older medicine that's sometimes used when other treatments have failed, especially for infections caused by certain types of bacteria that are hard to get rid of.

The main aim of this study is to understand how your body handles this medicine. Think of it like this: when you take a medicine, your body absorbs it, uses some of it to fight the infection, and then gets rid of it. This process is called 'pharmacokinetics'. By studying this, doctors can learn how much medicine is needed to be effective, how often it should be given, and what the safest amount is. This information is really important for making sure patients get the best possible treatment.

This is an early-stage study, meaning researchers are gathering fundamental information about the medicine's behaviour in the body. The findings from studies like this help doctors to make informed decisions about prescribing the medicine and, hopefully, to develop clearer guidelines for using it to fight serious infections in patients who don't have many other choices.

Key takeaways

This study helps understand how a special medicine fights serious infections.
It's for adults with difficult-to-treat infections.
The goal is to find the best way to give the medicine.
Participation involves taking the medicine and giving blood samples.
You can stop participating at any time.
It contributes to better treatment options for the future.

Who may be eligible?

To be considered for this study, you must be 18 years old or over. Both men and women can take part.

The study is specifically looking for people who have serious infections caused by certain types of bacteria that are very difficult to treat. This means that if you've tried other standard treatments for your infection and they haven't worked, this study might be an option for you.

The research team will carefully check your health and medical history to make sure that taking part in the study is safe for you and that you meet all the specific requirements. They'll explain everything in detail if you're interested.

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 that's hard to treat?
Have other treatments for your infection not worked well?
Are you able to attend appointments and give blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will explain everything to you in detail. Generally, it will involve giving blood samples at different times after you've been given the study medicine. This helps them measure how much of the medicine is in your body over time.

You might have a short stay in a clinic or hospital for some of these assessments, or you might need to make several visits to the study clinic. You'll be given the study medicine, colistimethate sodium, as part of your treatment for your infection. The total duration of your participation will depend on the specific schedule of blood tests and how long you need the medication, but the research team will give you a clear timeline before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is receiving a treatment for a serious infection for which other options might be limited, and contributing to medical knowledge that could help future patients. Potential risks could include side effects from the study medicine, which your doctor will discuss with you, or discomfort from blood tests. You are always free to leave the study at any time, for any reason, without it affecting your usual 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
Czechia

Common questions

What kind of infections is this medicine for?

It's for very serious infections caused by specific types of bacteria that are hard to treat with other medicines.

What does 'pharmacokinetic study' mean?

It means the study is looking at how your body handles a medicine – how it absorbs it, uses it, and gets rid of it.

Will I have to stay in hospital?

You might need to stay in a clinic or hospital for some of the tests, or you might have regular clinic visits. The team will tell you the exact plan.

Can I stop being part of the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.

Who is running this study?

This is a Human Pharmacology (Phase I) study, which means it's an early-stage study focusing on how the medicine works in people.