Dalbavancin for Acute bacterial skin and skin structure infection (ABSSSI)|Erysipelas

Inclusion criteria

• {"criterion_text":"- Patients with limited skin and soft tissue infection and clinical indication for systemic therapy under inpatient conditions: a. Clinical diagnosis of limited skin and soft tissue infection: i. Uncomplicated erysipelas (well-defined redness, swelling, pain, warmth) OR ii. Limited cellulitis (warm, edematous, painful, dark or livid redness, or doughy swelling AND iii. Surface area ≥ 75cm² OR <75cm² with additional marked systemic infection signs such as fever, chills, general condition reduction, CRP ≥ 10mg/dl, leukocytosis > 15,000/µl, IL-6 ≥ 50pg/mL b. AND one of the following criteria: a) Conclusively abnormal laboratory results (CRP, leukocytosis, IL-6) b) Conclusive (recently anamnestic) symptoms (fever, chills) c) Failure of oral (pre-)treatments or oral therapy not tolerated/feasible as an administration route\n- Written consent to participate in the study\n- Age ≥ 18 years, <85 years\n- Adequate home care for early discharge is foreseeable\n- Laboratory exclusion of pregnancy in women between 18 – 55 years (ß-hCG) (not necessary if postmenopausal for ≥ 2 years or surgically sterile)"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity/allergy to Dalbavancin or other glycopeptide antibiotics.\n- No prior therapy with Dalbavancin/Oritavancin/other glycopeptides within 7 days before study enrollment.\n- Uncomplicated soft tissue infection with an area of < 75 cm² and mild/no systemic infection signs such as fever, chills, reduced general condition.\n- Complicated, i.e., hemorrhagic, necrotizing erysipelas (with limited coverage of the potentially expected spectrum of microorganisms), soft tissue infection with retention, abscess formation, or indication for surgical drainage, soft tissue infection with gas formation, critical location with the risk of severe consequences of propagated purulent inflammation (e.g., hand or facial area), known or suspected involvement of anaerobic organisms (e.g., perineal wound infection, buttock decubitus, perianal abscess, wound infection related to surgical procedures in the gastrointestinal or female genital tract), presence of sacral decubitus or perirectal abscess in the inflammatory area as a potential entry point.\n- Severe infection with signs of sepsis such as hemodynamic compromise requiring treatment, and severe pain.\n- Active tumor disease.\n- Relevant immunosuppression (e.g., chemotherapy).\n- Severe impairment of arterial blood supply (pAVK III-IV) or venous circulatory disorder (CVI III) in the area of infection.\n- Chronic kidney insufficiency with creatinine clearance <30 ml/min.\n- Liver failure Child Pugh B, C.\n- Heart failure (NYHA III or IV).\n- Recent contamination with a problematic microorganism (VRE, 3MRGN, 4MRGN).\n- Diabetes mellitus HbA1c > 8.5% (if value is known), diabetic foot syndrome.\n- Affected region anatomically connected to prosthetic materials (e.g., permanent pacemaker battery packs or joint replacement prostheses).\n- Infection area involving intravascular graft or other superficially accessible foreign material (e.g., intravascular central venous catheter, Port-a-Cath, etc.). Excepted are coronary stents, inferior vena cava filters with a dwell time of more than 6 weeks, \"non-hemodialysis grafts\" with a dwell time of more than 90 days, and \"hemodialysis grafts\" that have not been in use for more than 12 months. Arteriovenous fistulas in dialysis patients are not considered foreign material.\n- Association with manifest infections in other anatomical locations or spaces, such as endocarditis or other endovascular infections, osteomyelitis, or septic arthritis.\n- Life expectancy < 3 months or indications of immediately life-threatening diseases, including but not limited to current or impending respiratory failure, shock, acute coronary syndrome, unstable cardiac arrhythmias, hypertensive emergencies, acute liver failure, active gastrointestinal bleeding, serious metabolic disorders, or acute cerebrovascular events.\n- Mental and psychiatric impairments or pre-existing conditions that may hinder safe participation in the study or could distort the results.\n- Poor adherence in the oral/ambulatory treatment setting: homeless individuals, elderly individuals, prisoners, parenteral drug users, socially isolated individuals, those living far from the hospital, presence of psychiatric disorders or alcohol abuse, physical impairments (frailty), inadequate home care ensured.\n- Pregnant and lactating women."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients who are dischargeable 48-72 hours after the Dalbavancin infusion due to sufficient infection control.","definition_or_measurement_approach":"Measured as the proportion (%) of enrolled patients judged dischargeable between 48 and 72 hours after dalbavancin infusion because of sufficient infection control."}
• {"endpoint_text":"- Incidence of adverse events during therapy (up to day 28).","definition_or_measurement_approach":"Measured as the incidence (number and proportion) of adverse events occurring during therapy up to day 28."}
• {"endpoint_text":"- Incidence of Dalbavancin-associated adverse events.","definition_or_measurement_approach":"Measured as the incidence (number and proportion) of adverse events assessed as associated with dalbavancin."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients who do not require readmission between hospital discharge and follow-up evaluation associated with infection.","definition_or_measurement_approach":"Measured as the proportion (%) of patients not readmitted for infection-related reasons between discharge and the follow-up evaluation."}
• {"endpoint_text":"- Percentage of inpatient patients who can be discharged on day 8 due to sufficient infection control","definition_or_measurement_approach":"Measured as the proportion (%) of inpatients deemed dischargeable on day 8 because of sufficient infection control."}
• {"endpoint_text":"- Proportion of patients who require readmission on day 8 due to insufficient infection control.","definition_or_measurement_approach":"Measured as the proportion (%) of patients readmitted on day 8 for insufficient infection control."}
• {"endpoint_text":"- Duration of hospitalization.","definition_or_measurement_approach":"Measured as length of hospital stay in days."}
• {"endpoint_text":"- Infection-associated rehospitalization rate within 4 weeks after discharge.","definition_or_measurement_approach":"Measured as the proportion (%) of patients rehospitalized for infection within 4 weeks after discharge."}
• {"endpoint_text":"- Percentage of patients without recurrent BHWI within 4 weeks after discharge.","definition_or_measurement_approach":"Measured as the proportion (%) of patients without recurrent bacterial/healthcare-associated wound infection (BHWI) within 4 weeks."}
• {"endpoint_text":"- Proportion of patients without recurrent BHWI within a 4-6 week follow-up period.","definition_or_measurement_approach":"Measured as the proportion (%) of patients without recurrent BHWI assessed during the 4–6 week follow-up."}
• {"endpoint_text":"- Percentage of patients requiring a change in antibiotic therapy (regimen change) within 14 days of starting treatment.","definition_or_measurement_approach":"Measured as the proportion (%) of patients who require an antibiotic regimen change within 14 days of treatment start."}
• {"endpoint_text":"- Proportion of patients with adequate antibiotic coverage by Dalbavancin according to the antibiogram.","definition_or_measurement_approach":"Measured as the proportion (%) of patients whose antibiogram indicates adequate coverage by dalbavancin."}

Austria

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Austria