NCT04671290已完成不适用
Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Rate of clinical cure
研究概览
简要总结
To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.
详细描述
Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature >38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination
- •Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E
- •Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems
排除标准
- •Multibacterial infection
- •Opposition to data collection according to GDPR
结局指标
主要结局
Rate of clinical cure
时间窗: Day 14 (End of antibiotic treatment according to national recommendations)
Number of patient in clinical cure is defined as the resolution of fever and symptoms of UTI present at antibiotic initiation (and no new symptoms) and the absence of clinical or microbiological failure.
次要结局
- Kinetic of fever defervescence(Baseline (day 0), day 3, day 7, day 14)
- Length of hospital stay(3 months after UTI diagnosis)
- Loss to follow-up, re-hospitalization, and mortality (safety endpoints)(3 months after antibiotic therapy initiation)
- Inflammatory biomarkers(Baseline (day 0), day 3, day 7, day 14)
- Relapse of UTI(3 months after antibiotic therapy initiation)
研究者
相似试验
Unknown
4 期
Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing EnterobacteriaceaeUrinary Tract InfectionsNCT02681263University Hospital, Grenoble25
撤回
4 期
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC EnterobacteriaceaeUrinary Tract InfectionNCT01543347Belpharma s.a.
进行中（未招募）
1 期
Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom - TEA trialEUCTR2008-005912-41-GBBelpharma SA/NV50
进行中（未招募）
1 期
AEUCTR2017-001257-14-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)350
撤回
4 期
PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream InfectionsBeta Lactam Resistant Bacterial InfectionEnterobacteriaceae InfectionsBacteremiaNCT05355350Rambam Health Care Campus1,000