2025-524877-18-00招募中4 期
Pilot Study - Safety and Efficacy of Dalbavancin in Early Outpatient Treatment of Erysipelas and Limited Cellulitis
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of patients who are dischargeable 48-72 hours after the Dalbavancin infusion due to sufficient infection control.
研究概览
简要总结
The primary objective of the study is to determine the safety and efficacy of Dalbavacin in early outpatient therapy for erysipelas and limited cellulitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •Written consent to participate in the study
- •Age ≥ 18 years, <85 years
- •Adequate home care for early discharge is foreseeable
- •Laboratory exclusion of pregnancy in women between 18 – 55 years (ß-hCG) (not necessary if postmenopausal for ≥ 2 years or surgically sterile)
排除标准
- •Hypersensitivity/allergy to Dalbavancin or other glycopeptide antibiotics.
- •Liver failure Child Pugh B, C.
- •Heart failure (NYHA III or IV).
- •Recent contamination with a problematic microorganism (VRE, 3MRGN, 4MRGN).
- •Diabetes mellitus HbA1c > 8.5% (if value is known), diabetic foot syndrome.
- •Affected region anatomically connected to prosthetic materials (e.g., permanent pacemaker battery packs or joint replacement prostheses).
- •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.
- •Association with manifest infections in other anatomical locations or spaces, such as endocarditis or other endovascular infections, osteomyelitis, or septic arthritis.
- •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.
- •Mental and psychiatric impairments or pre-existing conditions that may hinder safe participation in the study or could distort the results.
- •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.
- •No prior therapy with Dalbavancin/Oritavancin/other glycopeptides within 7 days before study enrollment.
- •Pregnant and lactating women.
- •Uncomplicated soft tissue infection with an area of < 75 cm² and mild/no systemic infection signs such as fever, chills, reduced general condition.
- •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.
- •Severe infection with signs of sepsis such as hemodynamic compromise requiring treatment, and severe pain.
- •Active tumor disease.
- •Relevant immunosuppression (e.g., chemotherapy).
- •Severe impairment of arterial blood supply (pAVK III-IV) or venous circulatory disorder (CVI III) in the area of infection.
- •Chronic kidney insufficiency with creatinine clearance <30 ml/min.
研究组 & 干预措施
Xydalba 500 mg powder for concentrate for solution for infusion
Test
干预措施: Xydalba 500 mg powder for concentrate for solution for infusion (Drug)
结局指标
主要结局
Percentage of patients who are dischargeable 48-72 hours after the Dalbavancin infusion due to sufficient infection control.
Percentage of patients who are dischargeable 48-72 hours after the Dalbavancin infusion due to sufficient infection control.
Incidence of adverse events during therapy (up to day 28).
Incidence of adverse events during therapy (up to day 28).
Incidence of Dalbavancin-associated adverse events.
Incidence of Dalbavancin-associated adverse events.
次要结局
- Proportion of patients who require readmission on day 8 due to insufficient infection control.
- Duration of hospitalization.
- Infection-associated rehospitalization rate within 4 weeks after discharge.
- Percentage of patients without recurrent BHWI within 4 weeks after discharge.
- Proportion of patients without recurrent BHWI within a 4-6 week follow-up period.
- Proportion of patients who do not require readmission between hospital discharge and follow-up evaluation associated with infection.
- Percentage of inpatient patients who can be discharged on day 8 due to sufficient infection control
- Percentage of patients requiring a change in antibiotic therapy (regimen change) within 14 days of starting treatment.
- Proportion of patients with adequate antibiotic coverage by Dalbavancin according to the antibiogram.
研究者
Martin Laimer
Scientific
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
研究点 (1)
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