跳至主要内容
临床试验/NCT06426212
NCT06426212招募中不适用

Use of Teicoplanin on a Three-weekly Administration in the Complex Outpatient Macroactivity Regimen of Infectious Diseases Unit in the Alessandro Manzoni Hospital (Lecco, Italy)

Azienda Ospedaliera di Lecco1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Describe the clinical characteristics and outcome of the study population.

研究概览

简要总结

Teicoplanin is an antibiotic belonging to the class of glycopeptides, in use since 1986. Like its older "classmate" vancomycin, it inhibits protein synthesis by interfering with the synthesis of peptidoglycan, and is active on Gram-positive bacteria such as Staphilococcus spp (including MRSA), Streptococcus spp and Enterococcus spp (both faecalis and faecium).

Teicoplanin is characterized by poor gastrointestinal absorption, which requires intramuscular or intravenous administration; has a binding to plasma proteins greater than 90%; and a high volume of distribution. It reaches high levels in deep tissues (bone, abdomen, lung, kidney, heart) on the contrary it has poor penetration at the central nervous system level; it is approved for the treatment of skin and soft tissue infections, osteo-articular infections, pneumonia, endocarditis, complicated urinary tract infections, peritonitis and bacteremia associated with the aforementioned clinical conditions. Furthermore, teicoplanin has a markedly long half-life (between 30 and 180h) which allows it to be administered even every 48-72h. Dose and duration of treatment should be adjusted according to the location and severity of the infection and based on patient characteristics such as renal function. The possibility of carrying out therapeutic drug monitoring (TDM) allows maintaining plasma levels adequate for the treatment of deep infections (e.g. >20 mg/l for endocarditis) and avoiding overdose.

Thanks to the possibility of administering teicoplanin on a three-weekly schedule, patient access to hospital is further reduced.

The investigators therefore propose a retrospective study to evaluate the clinical effectiveness of teicoplanin therapy according to a three-weekly scheme by comparing its use in the treatment of deep infections (deep seated infections - DSIs) and superficial infections (non-deep seated infections - NDSIs).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years;
  • Patients with documented Gram-positive infection sensitive to teicoplanin;
  • Patients who have received at least 4 doses of teicoplanin on a three-weekly schedule, as monotherapy or associated with other antibiotics

排除标准

  • Hospitalized patients
  • Patients who have received less than 4 doses of teicoplanin for any cause.

研究组 & 干预措施

patients with deep infections (deep seated infections - DSIs)

干预措施: Use of teicoplanin three times a week (Drug)

patients with superficial infections (non deep seated infections - NDSIs).

干预措施: Use of teicoplanin three times a week (Drug)

结局指标

主要结局

Describe the clinical characteristics and outcome of the study population.

时间窗: 2 months

Describe the clinical characteristics of patients and outcome (recovery vs therapeutic failure intended as death, need for modification of antibiotic therapy or recurrence of infection) of the study population.

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera di Lecco
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefania Piconi

Director of Infectious Diseases Unit

Azienda Ospedaliera di Lecco

研究点 (1)

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