EUCTR2007-005268-29-ES进行中(未招募)不适用
Eficacia y seguridad del tratamiento de infecciones nosocomiales graves causadas por Acinetobacter baumannii multirresistente con rifampicina más imipenem.Efficacy and safety to the treatment of severe nosocomial infections caused by multiresistant Acinetobacter baumannii with rifampin plus imipenem.
niversity Hospital Virgen del Rocío, Andalousian Health Service0 个研究点开始时间: 2007年11月26日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
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 must be iqual or older than 18 years.
- •* Patient must have 60 kilograms of weight or higher.
- •* Hospital stay more than 72 hours.
- •* Female patient of child bearing potential must have a negative serum pregnacy test prior to enrollment and must agree to practice effective birth control during the study.
- •* Acinetobacter baumannii infection with any of the following diagnosis:
- •- bacteremia
- •- nosocomial pneumonia
- •- complicated skin and soft-tissue infection
- •* MIC (minimun inhibitory concentration) of imipenem < or equal to 32 mg/L and MIC of rifampicin < or equal to 4 mg/L (E- test).
- •* Patient or legal representative must sign an informed consent form, approved by the Ethics Committee.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* Refractary shock or another illness that, in investigator opinion, the patient life expectancy is less than 48 hours.
- •* Patient with non-resucitation order.
- •* Infect¡ous endocarditis, osteomyelitis, or meningitis, suspected or confirmed.
- •* Hypersensitivity to betalactams or rifampicin, prior to study.
- •* Prior chronic liver disease or alcoholism.
- •* Acute hepatitis or simultaneous hepatotoxic drugs administration.
- •* Patient has been treated with non-authorized drugs during the last 30 days.
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