EUCTR2007-005112-37-AT进行中（未招募）不适用
An randomized, controlled, investigator-blinded, prospective, mono-centre study to evaluate the efficacy of fosfomycin versus meropenem in patients with complicated urinary tract infections - urosepsis/fosfo vs. meropenem
Medizinische Universität Wien, Abteilung für Interne Medizin I0 个研究点目标入组 240 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •1.Written informed consent to participate in the study.
- •2.Male or female patient of 18 years of age or older.
- •3.Patient suffers from documented complicated urinary tract infection.
- •4.Requires intravenous broad-spectrum anti-microbial therapy
- •5.Patient suffers from renal dysfunction indicated by a creatinine clearance =40 ml/min as determined by the Cockcroft-Gault equation using actual body weight (Appendix 4).
- •6.Negative urine pregnancy test in females of childbearing potential
- •7.Patient is willing to participate in the study, follow protocol study
- •8. bacteruria 10 high 6/ml
- •9. CRP higher than 5mg/dl
- •treatment regimen, and comply with all planned assessments.
- •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
- •1.Treatment with study drugs within the past three weeks prior to study enrolment.
- •2.No source of infection other than infection of the urinary tract
- •3.Current therapy with other antimicrobial agents
- •4.History of hypersensitivity to the study drug(s) or to drugs with similar chemical structures.
- •5.Patients submitted to the hospital with known pathogens resistant to study drugs
- •6.Patient with a neutrophils count <1000/m3.
- •7.Use of any other investigational therapy at the time of enrolment, or within 30 days or 5 half-lives of inclusion into, whichever is longer.
- •8.Patients unable or unwilling to adhere to the study-designated procedures and restrictions.
- •9.Unable to understand the nature, purpose and extent of the study
研究者
相似试验
已完成
4 期
A randomized, controlled, investigator-blinded, multicenter, single-cross-over interventional pilot study to investigate the effect of virtual reality enhanced education on rheumatoid arthritis for healthcare professionals on knowledge, illness perception and empathy toward patients with rheumatoid arthritis: the VENTURE trialHealthcare Professionals working in RheumatologyDRKS00021507Justus Liebig Universität Gießen, Campus Kerckhoff, Abt. für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin40
进行中（未招募）
1 期
Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisMedDRA version: 23.0Level: LLTClassification code 10083611Term: Non-cystic fibrosis bronchiectasisSystem Organ Class: 100000004855BronchiectasisEUCTR2019-002840-26-GBovartis Pharma AG72
进行中（未招募）
1 期
Study of LIK066 in overweight and obese women with polycystic ovary syndromepolycystic ovary syndromeMedDRA version: 20.0Level: LLTClassification code 10036050Term: Polycystic ovarySystem Organ Class: 100000004872EUCTR2017-001373-16-DEovartis Pharma AG29
进行中（未招募）
1 期
Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisMedDRA version: 23.0Level: LLTClassification code 10083611Term: Non-cystic fibrosis bronchiectasisSystem Organ Class: 100000004855BronchiectasisEUCTR2019-002840-26-DEovartis Pharma AG72
进行中（未招募）
1 期
Study to assess the efficacy and safety of CJM112 in patients with inadequately controlled severe asthmaInadequately controlled moderate to severe asthmaMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2017-000205-21-DKovartis Pharma AG110