NCT02782078已完成不适用
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- clindamycin AUC (area under curve) at steady state and after rifampicin introduction
研究概览
简要总结
Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin
详细描述
It could suggest modification of recommended doses or incitement to antibiotic dosage. Thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •patients ≥18 years of age
- •osteoarticular infection
- •staphylococcus detected in bacteriological sampling
- •sensibility to rifampicin, erythromycin and clindamycin
- •active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling
排除标准
- •septic shock or severe initial sepsis
- •osteoarticular infection with other microorganism than staphylococcus
- •contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics
- •pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance <30 ml/min)
- •serious cognitive disorders
- •patient under guardianship, trusteeship or non affiliated to social security or CMU (beneficiary or assignee)
- •refusal to take part in the study and to sign the consent form
- •pregnancy
- •lactation
- •administration of clindamycin or rifampicin within the month before inclusion
- •treatment with enzymatic inductor or inhibitor within the month before inclusion
- •participation to another study modifying antibiotic treatment administration
结局指标
主要结局
clindamycin AUC (area under curve) at steady state and after rifampicin introduction
时间窗: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction
this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0
次要结局
- biological outcome(at day 4, day 14, day 28 (or day 60 if osteosynthesis))
- side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0(at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis))
- clinical outcome(at day 4, day 14, day 28 (or day 60 if osteosynthesis))
- rifampicin auto induction(AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction))
研究者
研究点 (2)
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