Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- To evaluate the timing of microbiological eradication
研究概览
简要总结
This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases.
The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.
详细描述
The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers).
This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy.
Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
- •Adult population (age ≥ 18 years)
- •Signed informed consent form
排除标准
- •Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs
- •Patients with negative blood cultures
- •Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms)
- •Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture
- •Patients treated with inappropriate therapy for more than 48 hours
- •Patients discharged early without follow-up blood cultures
- •History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)
结局指标
主要结局
To evaluate the timing of microbiological eradication
时间窗: Within two weeks from the antibiotic therapy initiation
To evaluate the timing of microbiological eradication in patients who received cefepime/enmetazobactam (FEP/META) compared to best available therapy (BAT) for targeted treatment of bacteremic complicated urinary tract infections (cUTIs) due to ESBL/OXA48 producers Gram-negatives
次要结局
- To investigate clinical cure(At day 3-7 after positive blood culture between two groups)