跳至主要内容
临床试验/NCT06899906
NCT06899906招募中不适用

Efficacy and Safety of Dalbavancin As Suppressive Therapy

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
33
试验地点
1
主要终点
efficacy of DAL treatment, measured as the proportion of stable infection

研究概览

简要总结

Dalbavancin (DAL) is a semi-synthetic antibiotic that belongs to the lipoglycopeptide family and is structurally derived from teicoplanin, respect of which it has two structural differences that enhance its anti-staphylococcal binding affinity and extend its half-life to between 149 and 250 hours. It achieves adequate tissue penetration in the skin, bones, joints, lung tissues, and peritoneal space, maintaining concentrations above the MIC for susceptible Gram-positive pathogen.

DAL is a bactericidal antimicrobial agent that binds the C-terminal D-alanyl-D-alanine on the bacterial cell wall, blocking trans-glycosylation and transpeptidation processes essential for cell wall synthesis. It seems also to be able to enhance neutrophil antibacterial activity improving PMNs' intracellular killing of MRSA. It has also a good antibiofilm activity, alone or in combination with other molecules. Like other glycopeptide molecules, DAL shares a similar spectrum of activity, with demonstrated in vitro activity against various Gram-positive bacteria, including Staphylococcus spp, Streptococcus spp and Enterococcus (faecium, and faecalis). Resistance to DAL is possible in these gram-positives bacteria, given to presence of enzymes that produce low-affinity binding precursors for the antibiotic's binding site. DAL is capable to overcome Van-B mechanism of resistance, but it results not active in producing Van-A strains.

The study objectives was to evaluate efficacy and safety of DAL treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • > 18 years
  • Patients received SAT with DAL for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between July 2019 and December 2024
  • Patient who was informed and did not object to participating in the study

排除标准

  • -< 18 years
  • Subjects who received DAL not for SAT purposes

结局指标

主要结局

efficacy of DAL treatment, measured as the proportion of stable infection

时间窗: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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