Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A randomized placebo-controlled double-blinded trial of the treatment of MRSA throat carriage with either standard decolonization therapy or standard decolonization therapy combined with oral clindamycin

This study is for people who have methicillin-resistant Staphylococcus aureus (MRSA) germs in their throat. MRSA is a type of bacteria that can be harder to treat with common antibiotics. The main goal of this study is to find out if combining a medicine called clindamycin with the standard treatment helps get rid of MRSA from the throat more effectively. We will check if the MRSA is gone after one month. We will also check again after six months to see if it stays away. This trial compares the new approach to the standard treatment alone, to see which works better. This could help doctors find better ways to treat MRSA in the throat in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Region Hovedstaden

Enrolment target

Start

23 Oct 2024

MRSA throat carriage

What is this study about?

This study is looking into a better way to treat a type of germ called MRSA, specifically when it's found in the throat. MRSA is a common germ that many people carry without getting sick, but it can sometimes cause infections. When MRSA is found in the throat, it's called 'MRSA throat carriage'.

Currently, there are standard ways to try and clear MRSA from the body. In this study, we're trying to find out if adding an antibiotic medicine called clindamycin to the usual treatment makes it more successful at getting rid of the MRSA in the throat.

We will compare two groups of people: one group will receive the standard treatment plus clindamycin, and the other group will receive the standard treatment plus a dummy pill (placebo). This helps us see if clindamycin really makes a difference. We'll check to see if the MRSA is gone from your throat after one month, and then again after six months.

Key takeaways

This study investigates a new treatment for MRSA in the throat.
It aims to see if adding clindamycin helps clear MRSA more effectively.
Participation involves taking medication and providing throat swabs.
The study is for adults over 18 with MRSA in their throat.
It could lead to better MRSA treatments in the future.

Who may be eligible?

This study is looking for volunteers aged 18 years and older. There is no upper age limit, meaning people of all adult ages can take part.

Both men and women are welcome to join this study. The main requirement for joining is that you have MRSA present in your throat.

Before you can officially join, the study team will carry out some checks to make sure this study is right for you and that you meet all the necessary health criteria. This is to ensure your safety and that the study results are clear.

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 MRSA germs found in your throat?
Are you able to attend clinic visits?
Are you willing to take study medication and provide swabs?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several visits to the clinic over a few months. You will be given either the standard treatment for MRSA throat carriage along with an antibiotic called clindamycin, or the standard treatment along with a dummy pill (placebo). Neither you nor your doctor will know which one you are receiving – this is to make sure the study results are fair.

You will need to provide swabs from your throat so we can test for MRSA at different times. The main check will be one month after you start treatment to see if the MRSA has cleared. There will be another check six months later to see if it has stayed away. The total duration of your active participation, including follow-up, will be several months.

Potential risks and benefits

Participating in this study might help us find better ways to treat MRSA in the throat in the future, which could benefit others. There's a chance that the treatment you receive might help clear your MRSA more effectively than standard treatment alone. However, like all medicines, clindamycin can have side effects, which the study team will explain to you in detail. You have the right 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
Denmark

Common questions

What is MRSA?

MRSA stands for methicillin-resistant Staphylococcus aureus. It's a type of germ (bacteria) that can live on your skin or in your nose or throat. It's often harmless but can sometimes cause infections.

What does 'throat carriage' mean?

It means the MRSA germ is present in your throat, but you might not have any symptoms or feel sick from it.

What is an antibiotic?

Antibiotics are medicines that fight infections caused by bacteria, like MRSA.

What is a 'dummy pill' or 'placebo'?

A dummy pill looks like the real medicine but contains no active drug. It helps compare the new treatment fairly.

Will I know if I'm getting the new medicine?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're getting the active medicine or the dummy pill until after the study is over. This ensures the results are unbiased.