EUCTR2016-002796-10-ES进行中(未招募)1 期
Assessment of intrapulmonary concentrations of meropenem administered by continuous infusion in postoperative pneumonia.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
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
- •Patients of both genres aged older than 18 years old at the screening visit.
- •Diagnosis of pneumonia in FRGMR post-operative patients . The diagnosis of pneumonia is based on clínical criteria and / or scores on the Clinical Infectious Pulmonary Score (PIACSS) = 6 points.
- •Admission at theIntensive Care postoperative Unit (ICUPQ): The patient've been admited to ICUPQ after a surgical intervention and been developed a pneumonia during this insgress.
- •Patients who have signed inform consent indicating that they have been informed regarding all the clinical trial aspects, or in the event that the subjects of the trial are incapacitated, signature of consent by the family member or legally designated representative.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Allergy or hypersensitivity to ß-lactamic antibiotics or any of the excipients of the drug clinical trial.
- •Administration of carbapenemics antibiotics in the previous 15 days to inclusion of the study.
- •Glomerular filtration <50 ml / min (GFR) (calculed by MDRD-4 formula (four-variable Modification of Diet in Renal Disease formula) or acute renal failure with renal indications of renal replacement.
- •Severe disruption of the function, liver cirrhosis, defined as Class C según the classification of Child-Pugh.
- •Obesity (BMI> 30).
- •Known colonization with pathogens with resistance to meropenem.
- •Life expectancy <3 days.
- •Pregnant women or breast feeding.
- •Participation in a clinical research dentro de los 3 months prior to administration of the drug.
研究者
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