EUCTR2019-002396-34-FR进行中（未招募）1 期
Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study - A2B-trial
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)0 个研究点目标入组 506 人开始时间: 2019年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 506
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
- •- Patient majeur âgé de plus de 18 ans et de moins de 80 ans
- •- Brûlés nécessitant au moins une intervention chirurgicale d'excision-greffe
- •- SCB entre 5 et 40 %.
- •- Consentement éclairé signé ou inclusion en vertu des dispositions d'urgence de la loi (article L1122-1-2 du DSP)
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •-Allergie sévère prouvée à la céphalosporine ou à la pipéracilline-tazobactam ou à tout autre agent antibactérien de la classe des pénicillines.
- •- Antécédents de réaction allergique grave à tout autre bêta-lactame (p. ex. céphalosporines, monobactames ou carbapénèmes).
- •- Patient sous antibiothérapie au moment de l'inclusion
- •- Patiente enceinte ou allaitante
- •- Patient non couvert par la sécurité sociale
- •- Patient transféré d'une autre unité de grands brûlés
- •- Patient participant à une étude expérimentale sur un médicament compétitif sur le critère d'évaluation principal
- •- Patient sous tutelle
- •- Patient sous curatelle
研究者
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