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A study to evaluate the safety and effectiveness of dalbavancin in patients with erysipelas or limited cellulitis being treated at home.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Erysipelas and Cellulitis, which are types of Acute bacterial skin and skin structure infection (ABSSSI). These conditions are infections of the skin and the deeper layers of tissue underneath caused by bacteria. The research aims to evaluate the safety and effectiveness of the drug dalbavancin for treating these infections in an outpatient setting, which means receiving treatment without staying overnight in a hospital.

Participants in the study will receive dalbavancin through an intravenous administration, meaning the medication is delivered directly into a vein via a liquid solution. The study will monitor how well the medicine works to control the infection and track any possible side effects that may occur during the treatment period.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    An intravenous infusion (medicine delivered directly into a vein) of dalbavancin at a dose of 1500 mg is administered.

  2. Step 2

    Monitoring and observation

    The infection is monitored to determine if discharge from the hospital is possible 48 to 72 hours after the medicine is given.

    Safety and side effects are monitored for up to 28 days.

  3. Step 3

    Follow-up period

    The status of the skin infection is evaluated during a follow-up period lasting between 4 and 6 weeks after the initial treatment.

Who can join the trial?

8 criteria

  • You must have a skin infection such as erysipelas (a type of skin infection with well-defined redness, swelling, pain, and warmth) or cellulitis (a skin infection characterized by warmth, swelling, pain, and dark redness).
  • If you have cellulitis, the affected area must be 75cm² or larger, or smaller than that if you also show signs of a widespread infection like fever, chills, feeling generally unwell, or having abnormal blood test results.
  • Abnormal blood test results include high levels of CRP (a marker of inflammation), leukocytosis (a high white blood cell count), or IL-6 (a protein that indicates inflammation).
  • You must have symptoms like fever or chills, or you must have tried taking medicine by mouth that did not work or could not be used.
  • You must be at least 18 years old but younger than 85 years old.
  • You must provide written consent, which means signing a document agreeing to take part in the study.
  • You must have enough support at home to take care of yourself after leaving the hospital.
  • Women between the ages of 18 and 55 must take a blood test to confirm they are not pregnant. This is not required if you have already gone through menopause (the end of menstrual cycles) for at least 2 years or have had surgery to prevent pregnancy.

Who cannot join the trial?

21 criteria

  • You have an allergy or a high sensitivity to Dalbavancin or other glycopeptide antibiotics, which are a specific group of medicines used to kill bacteria.
  • You have moderate to severe liver failure, which means your liver is not working properly to clean your blood.
  • You have advanced heart failure, a condition where the heart cannot pump blood well enough to meet the body's needs.
  • You have a recent infection caused by problematic microorganisms, such as VRE or multi-drug resistant bacteria, which are germs that are very difficult to treat with standard medicines.
  • You have diabetes mellitus with an HbA1c level higher than 8.5% (HbA1c is a measure of average blood sugar over the past few months) or you have diabetic foot syndrome.
  • The area of your skin infection is located near prosthetic materials, such as a pacemaker (a device that helps control the heartbeat) or a joint replacement (artificial parts used in joints like the hip or knee).
  • The infection area involves a foreign material inside a blood vessel, such as a catheter (a thin tube used to give medicine or fluids) or a Port-a-Cath (a device implanted under the skin to allow easy access to veins).
  • You have infections in other parts of the body, such as endocarditis (infection of the heart lining), osteomyelitis (bone infection), or septic arthritis (infection in a joint).
  • You have a life expectancy of less than 3 months or any life-threatening diseases, such as respiratory failure (difficulty breathing), shock (sudden drop in blood flow), acute coronary syndrome (sudden heart problems), unstable cardiac arrhythmias (irregular heartbeats), or acute cerebrovascular events (such as a stroke).
  • You have mental or psychiatric conditions that might make it difficult to participate safely or could affect the study results.
  • You may face challenges following the treatment plan, such as being homeless, living in social isolation, living far from the hospital, or having physical impairments or alcohol abuse.
  • You have taken Dalbavancin, Oritavancin, or other glycopeptides within the last 7 days.
  • You are pregnant or currently breastfeeding.
  • The skin infection is too small (less than 75 square centimeters) and you do not show signs of being sick, such as fever or chills.
  • The infection is complicated, meaning it involves abscess formation (a collection of pus), necrosis (dead tissue), or requires surgery to drain.
  • The infection is in a critical location, such as the face or hands, or involves anaerobic organisms (bacteria that grow without oxygen), such as in a wound near the groin or bottom.
  • You have a severe infection with signs of sepsis, which is a life-threatening reaction to an infection that affects the whole body.
  • You have an active tumor or cancer.
  • You have immunosuppression, which means your body's ability to fight infection is weakened, for example, due to chemotherapy.
  • You have severe problems with blood circulation, such as pAVK (poor blood flow in the arteries) or CVI (problems with blood flow in the veins) in the area of the infection.
  • You have chronic kidney insufficiency, meaning your kidneys are not working well, specifically if your creatinine clearance (a measure of how well kidneys filter blood) is less than 30 ml/min.
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Investigated drugs

Dalbavancin is an antibiotic medication given through a vein to help treat skin infections like erysipelas and cellulitis.

What is already known about the treatment

Dalbavancin - This medication is an antibiotic given as a liquid through a vein during an infusion. It is an established medicine used primarily to treat serious skin and skin structure infections caused by bacteria. The drug works by preventing bacteria from building their protective cell walls, which ultimately causes the bacteria to die. It belongs to a class of drugs known as lipoglycopeptides.

Investigated diseases

Erysipelas - This is a bacterial infection that affects the upper layers of the skin. It typically causes the skin to become red, swollen, and warm to the touch. The affected area often has clearly defined edges and may feel firm. As the condition progresses, the redness can spread quickly across the skin. It may also be accompanied by localized discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524877-18-00Protocol codeSIWIDA-FAT 001Estimated enrolment50 patientsSponsorGemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

sourced from the EU Clinical Trials Register and site verification

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