Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of the decolonization rate and acceptance of a complete nasal decolonization kit with povidone iodine for MRSA patients (MRSAD-PVP-I)

This study is for people who have a germ called MRSA in their nose. It wants to find out how good a special kit is at removing this germ. The kit includes a mouthwash, a gel, and a skin wash, all containing a germ-killing ingredient. Researchers will check if the MRSA is gone from the nose a few hours after using the kit. They will also ask patients and healthcare workers how easy and comfortable the kit was to use. This information helps doctors understand the best ways to treat MRSA and make sure treatments are simple for patients to use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

Start

17 Jan 2023

MRSA patients

What is this study about?

This study is looking into a common germ called MRSA, which sometimes lives harmlessly in people’s noses but can cause problems if it gets into other parts of the body. Doctors often want to remove MRSA from the nose, a process called decolonization. This particular study is testing a new kit designed specifically for this purpose.

The kit contains several items that all have a germ-killing ingredient called povidone-iodine. These include a mouthwash, a cleansing gel, and a special skin wash. The main goal of the study is to see how effectively this kit removes MRSA from the nose. Researchers will check to see if the MRSA is gone just a few hours after people use the kit. They will also do another check a day later to see if it's still clear.

Another important part of the study is to understand how people feel about using the kit. They will ask patients and the healthcare staff helping them if the kit was easy and comfortable to use. This feedback is really important because treatments are only good if people can and will use them properly. They will also keep an eye on any side effects and learn more about why the treatment might not work for some people.

Key takeaways

This study evaluates a kit to remove MRSA from the nose.
It checks how well the kit works and if it's easy to use.
The kit includes mouthwash, gel, and skin wash.
Adults with MRSA in their nose can potentially join.
Participation helps improve future MRSA treatments.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so older adults are welcome to participate too. Both men and women can take part in this research.

The most important thing is that you must have MRSA (a specific type of germ) found in your nose. The study is specifically designed for people who have this particular germ in their nasal passages. If you don't have MRSA in your nose, this study might not be the right fit for you.

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 found in your nose?
Are you willing to use the decolonization kit as instructed?
Are you able to provide feedback on your experience with the kit?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would use a special germ-killing kit. This kit includes a mouthwash, a gel, and a skin wash designed to help remove MRSA from your nose. After you use the kit, the study team will take a sample from your nose (like a swab) to see if the MRSA is gone, usually within 6 hours. They will also do another check 24 hours later. You will also be asked to fill out a short questionnaire about how you felt using the kit. The healthcare staff involved will also share their thoughts on the kit's ease of use. The exact number of visits or the total duration of your participation would be explained in more detail by the study team, but it primarily focuses on the immediate effects of using the kit.

Potential risks and benefits

Taking part could help doctors understand better ways to get rid of MRSA from people's noses, potentially leading to easier and more effective treatments in the future. As with any medicine, there's always a chance of side effects from the products in the kit, like skin irritation, though these are usually mild and temporary for this type of product. The study team will carefully monitor you for any problems. Remember, your participation is completely voluntary, and you can change your mind and withdraw from the study at any time without giving a reason.

Locations (1)

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

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Unverified
France

Common questions

What is MRSA?

MRSA is a common germ (bacteria) that can sometimes live in people's noses without causing harm, but it can also cause infections if it gets into other parts of the body.

What is 'nasal decolonization'?

This is a medical term for clearing germs, like MRSA, from the inside of your nose, often using special washes or creams.

What's in the kit?

The kit contains a mouthwash, a gel, and a skin wash, all with an antiseptic (germ-killing) ingredient called povidone-iodine.

Will I know if the treatment worked?

The study aims to check if the MRSA is gone from your nose shortly after using the kit. The study team will take samples to find this out.

What is a Phase II study?

This means it's an early-stage study focusing on how well the treatment works and its safety, after initial safety checks have been done.