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临床试验/NCT02897648
NCT02897648终止不适用

Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年6月26日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Assessment of change of residual concentration of Beta-Lactam antibiotic

研究概览

简要总结

The route of subcutaneous administration of drugs has become a common practice in some specialties (palliative care, geriatrics).

This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by subcutaneous route but few clinical studies evaluating the level of scientific relevance justifies their use.

The purpose of this study is to assess:

  1. / Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD of Beta lactam objectives in a geriatric population.
  2. / The safety and lack of toxicity of administrations subcutaneously.

Advantages disadvantages

  • easy Of establishment
  • Simplicity Monitoring and manipulation
  • Reduced Risk of infection
  • No Risk of venous thrombosis
  • Lower cost Simple -Technique for support at home taking
  • Limitation Aggressive gestures
  • multiplicity Of all possible injection sites
  • Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL / 24 / site)
  • Use Impossible for some drugs
  • Risk Discomfort and intolerance at the injection site

A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the administration of antibiotics.

Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%); the absence of marketing authorization for the subcutaneous route (34.5%); the absence of serum assay available (2.1%).

详细描述

PROTOCOL

Primary objective :

• Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD objectives Beta lactam in a geriatric population.

Secondary objectives:

  • Clinical evaluation at J14 and J90 (healing, death)
  • Clinical tolerance of subcutaneously by self-assessment or hetero-evaluation of the existence of cognitive disorders

研究设计

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

入排标准

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

入选标准

  • Geriatric Population (≥ 75 years)
  • Infection may cause bacteremia or not: Gram-negative bacilli and gram-positive cocci susceptible to beta-lactam

排除标准

  • Patient Refusal expressed or legal guardian
  • polymicrobial infection

结局指标

主要结局

Assessment of change of residual concentration of Beta-Lactam antibiotic

时间窗: Minute 30, hour 24, Day 7. Then once a Week 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

• Making systematic assay serum concentrations of residual antibiotics in the range of 30 min prior to reinjection H24 after starting treatment and then weekly monitoring.an

次要结局

  • Assessment of patient healing (infection free)(Day 14 and day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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