AuthorisedTherapeutic use (Phase IV)Interventional

Pilot Study - Safety and Efficacy of Dalbavancin in Early Outpatient Treatment of Erysipelas and Limited Cellulitis

This study is looking into a medicine called Dalbavancin, also known as Xydalba, to treat common skin infections like erysipelas and certain types of cellulitis. These infections can make your skin red, swollen, and painful. This research is a 'Phase IV' study, which means the medicine is already approved, and scientists are now gathering more information about its real-world benefits and any side effects when used in the early stages of treatment outside the hospital. The main goals are to see how many patients can safely go home within 48 to 72 hours after getting the Dalbavancin treatment because their infection is under control, and to track any side effects that might happen. It also checks if patients stay well after leaving the hospital.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Enrolment target

Start

07 Apr 2026

Acute bacterial skin and skin structure infection (ABSSSI) Erysipelas

What is this study about?

This research is looking at a medicine called Dalbavancin, sometimes known by its brand name Xydalba, for treating common skin infections. These infections, like erysipelas and certain types of cellulitis, can cause the skin to become red, swollen, and warm. They are caused by germs (bacteria) and can sometimes require a hospital stay.

The main idea behind this study is to see if Dalbavancin can help people get better quickly, especially in the early stages of the infection. The researchers want to find out if enough people can be treated successfully and sent home within a few days (48 to 72 hours) after getting the medicine. This could mean less time spent in the hospital, which is often better for patients.

Beyond getting people home faster, the study is also very focused on safety. It will carefully check for any side effects or unwanted reactions that might happen with Dalbavancin, both during the treatment period and for a few weeks afterward. Understanding both how well a medicine works and if it's safe is really important for doctors and patients.

Key takeaways

Study examines Dalbavancin (Xydalba) for specific skin infections.
Aims for earlier discharge from hospital for suitable patients.
Carefully checks for safety and any side effects.
Involves regular check-ups and follow-up after hospital.
Study helps doctors understand the medicine better.
Participation is voluntary, you can withdraw anytime.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with certain types of acute bacterial skin and skin structure infections, which include erysipelas and some forms of cellulitis.

It's important to remember that the specific details of your health condition would be checked carefully by the study doctors to make sure this is the right study for you. There might be other reasons why someone couldn't join, depending on their overall health and other medicines they might be taking. The study team will explain all of this clearly.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with erysipelas or certain types of cellulitis?
Are you able to attend follow-up appointments?
Are you willing to receive treatment through an intravenous (IV) drip?
Are you a resident of the UK?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would receive the medicine Dalbavancin (Xydalba) through a drip (infusion) into your vein. The study team would carefully monitor your health and how your infection is responding to the treatment. They would track any side effects you might experience. You would have appointments where your health would be checked and samples might be taken, such as blood tests, to see how the medicine is working and to monitor your general health. There would likely be follow-up appointments after you leave the hospital, possibly up to 4 to 6 weeks, to make sure your infection hasn't come back and you're feeling well. The total time you'd be involved in the study would depend on how your infection progresses and the follow-up schedule.

Potential risks and benefits

Taking part in this study could potentially allow you to go home sooner if the Dalbavancin successfully treats your infection quickly. It also contributes to doctors gaining more knowledge about how best to use this medicine for skin infections. However, like all medicines, Dalbavancin can have side effects, which the study team will monitor closely. There might also be unknown risks, as is the case with medical studies. You are always free to decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Austria

Common questions

What kind of skin infections is this study looking at?

This study is for specific serious skin infections caused by bacteria, including erysipelas and a limited type of cellulitis. These can make your skin sore, red, and swollen.

What is Dalbavancin (Xydalba)?

Dalbavancin is a medicine given through a drip (infusion) that helps fight certain types of bacterial infections. It's already approved for use, and this study looks at how well it works in a specific situation.

Will I have to stay in the hospital?

The study aims to see if patients can safely go home quickly (within 2-3 days) after getting Dalbavancin, once their infection is under control. So, the goal is for shorter hospital stays if possible.

What are the main things the doctors want to find out?

They want to know how many people can go home soon after treatment and if the medicine causes any side effects. They also want to see if the infection stays away after you leave the hospital.

Is this medicine new?

No, Dalbavancin (Xydalba) is already an approved medicine. This study is a 'Phase IV' study, which means it's gathering more information about its use in real-world situations, like treating these skin infections early on.