EUCTR2015-003972-64-FR进行中（未招募）1 期
Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients - AMIKACINE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age minimal 18 years old.
- •male or female
- •Burn skin infection supported by percutaneous administration of amikacin. Presence of positive local signs of bacterial cutaneous infection meeting the criteria as defined by the French Society of Brulology (SFB):
- •Presence of a local or locoregional inflammatory reaction
- •o an unfavorable and unexpected local evolution
- •at the burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
- •at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
- •at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
- •at the level of healed areas: impetigo, lysis of healed areas.
- •Presence of a local or locoregional inflammatory reaction
- •and or an unfavorable and unexpected local evolution
- •At the level burns: presence of pus, fast debridement, appearance of black spots (necrosis or haemorrhage), unexplained conversion of a superficial lesion to a deep lesion (> 48h)
- •at the level of engraftment: presence of pus, unexplained healing delay, pressure ulcer
- •at the level of the grafts: presence of pus, lysis of the grafts, necrosis of the fat located under the graft
- •at the level of healed areas: impetigo, lysis of healed areas.
- •subject benefiting from social security
- •Subject agreeing to participate in the study and having signed an informed consent
- •Subject mastering the French language.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Minor subject or pregnant or breastfeeding woman
- •Subject deprived of liberty
- •Subject under guardianship or guardianship
- •Subject does not have social security
- •Subject not accepting to participate in the study
- •subject having
- •Allergy to amikacin or other aminoglycoside antibiotic
- •Myasthenia gravis
- •Subject withdrawing consent during the study
- •Patients receiving intravenous aminoglycoside during local treatment.
研究者
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