A Randomized, Controlled, Multicentre Trial of Collateral Damage on the Intestinal Microbiota Inferred by Temocillin Versus Cefotaxime in Patients Receiving Empirical Treatment for Febrile Urinary Tract Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 12
- 主要终点
- Number of patients with emergence of any of the two following events: Colonisation or infection with C. difficile and/or with Enterobacteriaceae resistant to 3rd generation cephalosporins. Measured in cultures from faecal samples.
研究概览
简要总结
This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.
详细描述
Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria. Temocillin is approved and marketed in a few European countries since the 1980´s but not in Sweden.
The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication.
The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy.
The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection.
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
- •Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:
- •Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency
- •Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital)
- •Positive urinalysis tests (U-Nitrit and/or U-LPK)
- •Have a pre-treatment baseline urinary culture obtained
- •Require iv antibacterial treatment of the presumed infection
- •Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC
- •Signed informed consent
排除标准
- •Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
- •Pregnant or nursing women
- •Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
- •Known chronic renal insufficiency (creatinine clearance < 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
- •Known colonization with ESBL
- •Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.
研究组 & 干预措施
Temocillin
Temocillin powder for solution för injection/infusion, per day 6 g (2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.
干预措施: Temocillin (Drug)
Cefotaxime
Cefotaxime powder for solution för injection/infusion, per day 3-6 g (1-2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.
干预措施: Cefotaxime (Drug)
结局指标
主要结局
Number of patients with emergence of any of the two following events: Colonisation or infection with C. difficile and/or with Enterobacteriaceae resistant to 3rd generation cephalosporins. Measured in cultures from faecal samples.
时间窗: Within 12 hours after the last dose of study drug.
Superiority analysis.
次要结局
- Bacteriological cure per patient and per pathogen measured as negative urine Culture <1000 CFU/ml.(7-10 days after discontinuation of antibiotic treatment (parenteral and oral).)
- Number of patients with early clinical response.(Within 12 hours after the 9th dose of study drug.)
- Early bacteriological response measured as negative urine Culture <1000 CFU/ml.(Within 12 hours after the 9th dose of study drug.)
- Number of patients with clinical cure in each treatment group.(7-10 days after discontinuation of antibiotic treatment (parenteral and oral).)
- Rate of patients with diarrhea (≥ 3 loose stools per day)(From the first dose of study drug until 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).)
研究者
Håkan Hanberger
Professor
Public Health Agency of Sweden