Study on the Genetic Determinants of Clindamycin/Rifampin Interaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance with clindamycin/rifampin combination therapy
研究概览
简要总结
Main objective- To study the influence of the polymorphisms of nuclear receptor proteins pregnane X receptor (PXR), Liver X receptor alpha (LXRα), and Cytochrome P450 (CYP450) on the clindamycin clearance during clindamycin/rifampin combination therapy.
Secondary objectives To study the influence of these polymorphisms on clindamycin clearance, before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on CYP450 activity before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on the increase of CYP450 activity after clindamycin/rifampin combination therapy To study the difference between the expected and observed clindamycin serum concentrations after dosage adjustment, in patients with clindamycin dosage adjustment after combination therapy with rifampin
详细描述
Eligible patients will be informed on the study during their hospitalisation in the unit for the treatment of bone and joint infection by the medical doctor. If they agree to participate in the study, the following samples will be performed :
-
After at least 24 hours of clindamycin therapy and before combination therapy with rifampin:
-
1 urine sample (5 mL) for CYP 450 activity phenotyping
-
1 blood sample (5 mL on ethylenediaminetetraacetic acid (EDTA) tubes) for measuring clindamycin serum concentration and genotyping
-
After ten days of clindamycin-rifampin combination therapy:
-
1 urine sample (5 mL) for CYP 450 activity phenotyping
-
1 blood sample (5 mL on EDTA tubes) for measuring clindamycin serum concentration and genotyping
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bone or joint infection
- •aged ≥ 18 years old
- •treatment with clindamycin/rifampin combination therapy > 10 days
排除标准
- •prescription of another treatment with potential action on CYP450
- •pregnant or breast feeding patient
结局指标
主要结局
Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance with clindamycin/rifampin combination therapy
时间窗: 10 days after onset of clindamycin/rifampin combination therapy
Impact of PXR, LXRα, CYP 450 3A4/A5 polymorphism on clindamycin clearance after combination clindamycin-rifampin therapy will be analyzed by studying the association of these polymorphisms and clindamycin serum concentrations.
次要结局
- Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity before combination therapy with rifampin(One to four days after onset of clindamycin therapy and before starting rifampin therapy)
- Difference between expected and observed clindamycine serum concentration after dosage adjustment, in patients after combination therapy with clindamycin and rifampin,.(10 days after onset of clindamycin/rifampin combination therapy)
- Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance before combination therapy with rifampin (clindamycin monotherapy)(One to four days after onset of clindamycin therapy and before starting rifampin therapy)
- Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity after clindamycin/rifampin combination therapy(10 days after onset of clindamycin/rifampin combination therapy)
研究者
Dr Valerie ZELLER
MD, principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon