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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Hospital of the Paracelsus Medical University Salzburg, Austria

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The primary objective of the study is to determine the safety and efficacy of Dalbavacin in early outpatient therapy for erysipelas and limited cellulitis.

Conditions and MedDRA coding

Acute bacterial skin and skin structure infection (ABSSSI) Erysipelas

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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
2. Written consent to participate in the study
3. Age ≥ 18 years, <85 years
4. Adequate home care for early discharge is foreseeable
5. Laboratory exclusion of pregnancy in women between 18 – 55 years (ß-hCG) (not necessary if postmenopausal for ≥ 2 years or surgically sterile)

Exclusion criteria 20

1. Hypersensitivity/allergy to Dalbavancin or other glycopeptide antibiotics.
2. No prior therapy with Dalbavancin/Oritavancin/other glycopeptides within 7 days before study enrollment.
3. Uncomplicated soft tissue infection with an area of < 75 cm² and mild/no systemic infection signs such as fever, chills, reduced general condition.
4. 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.
5. Severe infection with signs of sepsis such as hemodynamic compromise requiring treatment, and severe pain.
6. Active tumor disease.
7. Relevant immunosuppression (e.g., chemotherapy).
8. Severe impairment of arterial blood supply (pAVK III-IV) or venous circulatory disorder (CVI III) in the area of infection.
9. Chronic kidney insufficiency with creatinine clearance <30 ml/min.
10. Liver failure Child Pugh B, C.
11. Heart failure (NYHA III or IV).
12. Recent contamination with a problematic microorganism (VRE, 3MRGN, 4MRGN).
13. Diabetes mellitus HbA1c > 8.5% (if value is known), diabetic foot syndrome.
14. Affected region anatomically connected to prosthetic materials (e.g., permanent pacemaker battery packs or joint replacement prostheses).
15. 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.
16. Association with manifest infections in other anatomical locations or spaces, such as endocarditis or other endovascular infections, osteomyelitis, or septic arthritis.
17. 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.
18. Mental and psychiatric impairments or pre-existing conditions that may hinder safe participation in the study or could distort the results.
19. 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.
20. Pregnant and lactating women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Percentage of patients who are dischargeable 48-72 hours after the Dalbavancin infusion due to sufficient infection control.
2. Incidence of adverse events during therapy (up to day 28).
3. Incidence of Dalbavancin-associated adverse events.

Secondary endpoints 9

1. Proportion of patients who do not require readmission between hospital discharge and follow-up evaluation associated with infection.
2. Percentage of inpatient patients who can be discharged on day 8 due to sufficient infection control
3. Proportion of patients who require readmission on day 8 due to insufficient infection control.
4. Duration of hospitalization.
5. Infection-associated rehospitalization rate within 4 weeks after discharge.
6. Percentage of patients without recurrent BHWI within 4 weeks after discharge.
7. Proportion of patients without recurrent BHWI within a 4-6 week follow-up period.
8. Percentage of patients requiring a change in antibiotic therapy (regimen change) within 14 days of starting treatment.
9. Proportion of patients with adequate antibiotic coverage by Dalbavancin according to the antibiogram.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Sponsor organisation

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Address

Muellner Hauptstrasse 48

City

Salzburg

Postcode

5020

Country

Austria

Scientific contact point

Organisation

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Contact name

Martin Laimer

Public contact point

Organisation

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Contact name

Martin Laimer

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications