Comparison of Ertapenem Distribution in the Muscle of Six Healthy Volunteers and Six Critically Ill Patients by Microdialysis
Ertapenem is an antibiotic that is highly bound to plasma protein (> 95%). The effects of this high protein binding on tissue distribution of antibiotics have been few evaluated yet.
In this study, two groups of subjects will be compared: 6 healthy volunteers and 6 critically ill patients (patients with infection due to an Ertapenem susceptible bacteria). Indeed, these 2 populations show changes in binding capacity of drugs to plasma proteins due to a decrease of protidaemia and of the affinity of drugs to transport proteins.
It seems therefore important to clarify the consequences of a modification in protein binding on distribution of antibiotics. That's why we have decided to characterize tissue distribution of ertapenem in healthy volunteers and critically ill patients by assessing: free and total concentrations in plasma and free concentrations in muscle by microdialysis.
研究概览
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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Poitiers、法国、86021
- Poitiers University Hospital - 2 rue de la Milétrie - Réanimation chirugicale
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: from 18 to 80 years
- Patients with infection due to ertapenem susceptible bacteria.
Exclusion Criteria:
- Patients who received ertapenem within 7 days prior to inclusion
- Known allergy to ertapenem or any excipients
- Neutropenia < 500/mm3
- Hemoglobin concentration < 9g/dl
- Renal failure (creatinin clearance < 30ml/min/1.73m²)
- Decompensated heart failure
- Patients receiving vasopressor (adrenalin, noradrenalin), > 0.5µg/kg/min
- Known hypersensitivity to Elma®
- Positive pregnancy test or currently lactating
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首次发布 (估计)
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与本研究相关的术语
其他研究编号
- ERTAMUSCLE
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