EUCTR2017-001257-14-FR进行中（未招募）1 期
Temocillin versus a carbapenem as initial intravenous treatment for extended-spectrum beta-lactamase related urinary tract infections, a non-inferiority study.TEMO-CARB - TEMO-CARB
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
- •- Adult (> or = 18 years)
- •- Hospitalized patient with clinically significant monomicrobial UTI (*)
- •- Complicated UTI (**) due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy
- •- Susceptibility (***) to temocillin and carbapenem as evidenced by testing results
- •- For woman able to procreate: negative pregnancy test in fertile women and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom). All forms of hormonal contraception are acceptable
- •- Signed informed consent
- •- Patient affiliated to the social security system
- •(*) UTI was defined according the SPILF guidelines [20] as pyuria (white blood cell count greater than 104/mL in urine) associated with clinical symptoms of urinary tract infection.
- •(**) Only complicated urinary tract infections (Pyelonephritis, prostatitis and renal abcess) will be included. Cystitis will be excluded.
- •Bacteriuria was defined as a bacterial culture > 103 UFC/mL.
- •(***) Susceptibility to temocillin and carbapenems will be determined according to CA-SFM 2015 guidelines.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Patient infected with a bacteria which is not an ESBL-producing enterobacteriacae.
- •- Patient infected with a strain resistant to temocillin.
- •- Polymicrobial infection.
- •- Hypersensitivity and/or previous intolerance to carbapenem or temocillin or penicillins or any other beta-lactam.
- •- Patient presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin due to Gram negative bacteria).
- •- Woman who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause).
- •- Palliative care of life expectance < 90 days.
- •- Ongoing empirical treatment of the urinary tract infections with carbapenem.
- •- Delay in randomization > 24 hours after identification of ESBL producing enterobacteriacaeae in urinary and/or blood culture.
- •- Participation in other clinical trial for the infection.
- •- Patient under tutorship or curatorship.
- •- Patient unable to give consent.
研究者
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