A Retrospective Observational Study to Assess the Clinical Management and Outcomes of Hospitalised Patients With Complicated Urinary Tract Infection in Countries With High Prevalence of Multidrug Resistant Gram-negative Bacteria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,028
- 试验地点
- 21
- 主要终点
- Treatment Failure
研究概览
简要总结
A retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)
详细描述
Bacterial resistance to antimicrobial drugs is a major public health problem. Of greatest concern is the rapid emergence and dissemination of resistance to third generation cephalosporins in Enterobacteriaceae, especially Escherichia coli and Klebsiella pneumoniae. This is frequently seen in association with resistance to other classes of antibiotics leading to a multidrug resistance (MDR) profile. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. In addition, in the last decade there has been an emergence of carbapenemase-producing Enterobacteriaceae, which are also resistant to other antibiotics than carbapenems, leaving few therapeutic options.
The overall aim of this study is to provide information about the epidemiology, clinical management and outcome of patients hospitalised with cUTI, including pyelonephritis. To achieve this aim, the investigators will perform a multicentre retrospective observational study in patients with hospitalised cUTI. The study will be conducted in several European countries plus Israel, which have a high prevalence of MDR Gram-negative bacteria (GNB), including Pseudomonas aeruginosa. The study will seek to identify possible modifiable risk factors for treatment failure, especially those related to antibiotic therapy.
On completion of this study, the investigators will develop a better understanding of the clinical management of hospitalised patients with cUTI due to MDR GNB in European countries. The investigators will identify the modifiable risk factors for treatment failure. This information will be used to inform better clinical and antibiotic management of cUTI to improve patient outcomes. The study will also be used in the development of hypothesis for future randomised controlled trials in cUTI with new antibiotics. Dissemination of results will take place through peer-reviewed publications and conference presentations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with UTI and at least one of the following underlying conditions:
- •Indwelling urinary catheter
- •Urinary retention (at least 100ml of residual urine after voiding)
- •Neurogenic bladder
- •Obstructive uropathy (e.g. nephrolithiasis, fibrosis)
- •Renal impairment caused by intrinsic renal disease: Estimated glomerular filtration rate (eGFR) <60 mL/min
- •Renal transplantation
- •Urinary tract modifications, such as an ileal loop or pouch
- •Pyelonephritis and normal urinary tract anatomy
- •and at least one of the following signs or symptoms:
- •Chills or rigors associated with fever or hypothermia (temperature greater than 38ºC or below 36ºC)
- •Flank pain (pyelonephritis) or pelvic pain (cUTI)
- •Dysuria, urinary frequency, or urinary urgency
- •Costo-vertebral angle tenderness on physical examination
- •UTI-related altered mental state
- •and at least one of the following microbiological results:
- •Urine culture with at least 105 CFU/mL or greater of a uropathogen (no more than 2 species)
- •At least one blood culture growing possible uropathogens (no more than 2 species) with no other evident site of infection
排除标准
- •Patients less than 18 years of age
- •Prostatitis
- •Polymicrobial infections that include Candida spp.
- •Polymicrobial infections that include more than 2 bacterial species
- •cUTI with Candida spp. as sole uropathogen
结局指标
主要结局
Treatment Failure
时间窗: 30 days
Treatment failure will be assessed as number of participants with evidence of treatment failure or mortality within 30 days from initial cUTI diagnosis
次要结局
- Time to death(30 days)
- Time to clinical response(30 days)
- Time to urological intervention for source control(30 days)
- Hospital mortality(30 days)
- All cause mortality within 30 days of the original cUTI diagnosis(30 days)
- All cause of mortality for two months after hospital discharge(60 days)
- Length of hospital stay(30 days)
- Readmissions to the hospital within 60 days of hospital discharge(60 days)
- Duration of antibiotic therapy(30 days)
- Cost per case of cUTI(30 days)
- Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection(30 days)
研究者
Miquel Pujol
PhD
Institut d'Investigació Biomèdica de Bellvitge