Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 19
- 主要终点
- Microbiological efficacy at Test of Cure in patients microbiologically evaluable
研究概览
简要总结
The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age of at least 18 year old
- •Patient benefits from social security
- •Signed informed consent
- •A urinary tract infection due to a confirmed ESBL producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy
- •Hospitalized patient
- •For women able to procreate: Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide and condom. (All forms of hormonal contraception are acceptable
排除标准
- •Patient infected with a bacteria which is not an ESBL-producing or AmpC hyperproducing Enterobacteriaceae
- •Patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole
- •Patients infected with a strain resistant to temocillin
- •Hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital)
- •Patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin.
- •Patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to Gram negative bacteria.
- •Patients needing concomitant antimicrobial therapy.
- •Septic shock
- •Children (up to 18 years old)
- •Women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause)
- •Patients with any kind of urinary/bladder catheter (JJ ureteral probe, ...)
- •Hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent
- •Chronically dialyzed patients
- •Patients having a creatinine clearance < 30 mL/min
- •Complete obstruction of the urinary tract
- •Perinephretic or intrarenal abscesses
- •Tutorship or curatorship patient
- •Patient unable to give his consent
研究组 & 干预措施
Temocillin
Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
Total antibiotic treatment between 10 and 14 days according to local guidelines (up to 21 days in immunosuppressed patients).
干预措施: Temocillin (Drug)
结局指标
主要结局
Microbiological efficacy at Test of Cure in patients microbiologically evaluable
时间窗: 7 days post end of Temocillin Treatment
The microbiological efficacy will be assessed by quantitative urine culture and defined as follows: * Eradication : \< 10\^3 CFU/mL of the baseline pathogen * Persistence : ≥ 10\^3 CFU/ml of the baseline pathogen * Superinfection : ≥ 10\^5 CFU/ml of another uropathogen during therapy * New infection : ≥ 10\^5 CFU/ml of another uropathogen after therapy * Relapse : eradication at TOC but ≥ 10\^3 CFU/mL of the baseline pathogen at FU Overall microbiological response will be determined as "unfavorable" if persistence or superinfection or new infection or relapse.
次要结局
- Clinical efficacy in clinical evaluable group(3 weeks for end of Temocillin Treatment)
- Development of resistance to temocillin during treatment(3 weeks for end of Temocillin Treatment)
- Microbiological efficacy(3 weeks for end of Temocillin Treatment)