Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 16
- 主要终点
- Clinical and microbiological cure
研究概览
简要总结
TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.
详细描述
Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen. Enterobacteriaceae are the most common bacteria involved in urinary tract infection. Since 2006, extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae have spread in France, as elsewhere. Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative. Although temocillin, 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections, it was not investigated in accordance with current standard. The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 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 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 by patient himself (able or under curatorship) or his legal representative (patient unable to give his consent or under tutorship)
- •Patient affiliated to the social security system
排除标准
- •Patient infected with a bacteria which is not an ESBL-producing enterobacteriaceae.
- •Polymicrobial infection.
- •Hypersensitivity and/or previous intolerance to carbapenem or temocillin, or penicillins or any other beta-lactam.
- •Patient with a contraindication to any of the drugs to be used in research
- •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 expectancy < 90 days.
- •Ongoing empirical treatment of the urinary tract infections with carbapenem or temocillin > 24 hours before randomization
- •Delay in randomization > 48 hours after identification of ESBL producing enterobacteriaceae in urinary and/or blood culture.
- •Participation in other clinical trial for the infection.
研究组 & 干预措施
Intravenous temocillin
Intravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h)
干预措施: Temocillin (Drug)
Intravenous meropenem or imipenem
Intravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy
干预措施: meropenem or imipenem (Drug)
结局指标
主要结局
Clinical and microbiological cure
时间窗: 5-7 days after end of treatment
The primary endpoint, was defined as achieving both clinical cure and microbiological eradication of all baseline pathogens 5-7 days after completion of treatment. Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy Microbiological efficacy will be assessed by quantitative urine culture and defined as follows \< 10\^3 Colony Forming Unit (CFU)/mL of the baseline pathogens
次要结局
- Clinical recurrences(60 days after randomization)
- Mortality(60 days after randomization)
- Frequency of oral antibiotic switch in both arms (temocillin vs. carbapenem)(60 days after randomization)
- Length of hospital stay(60 days after randomization)
- Persistent cure rate(60 days after randomization)
- Microbiota impact study(Time Frame : 5-7 days after treatment completion)
- Early microbiological eradication(3-4 days after randomization)
- Pharmacokinetic of temocillin according to kidney function(3 days after treatment initiation)