The Efficacy and Safety of Pivmecillinam in Treating Bacteriemic Urosepsis Caused by E.Coli
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Clinical efficacy
研究概览
简要总结
Febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. The duration of parenteral treatment depends on oral alternatives. These alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". The increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant E.coli to quinolones in Norwegian isolates.
Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for treating febrile urinary tract infections is insufficient. This trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by E.coli.
The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.
详细描述
This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational study with intention to treat. Participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day 4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for physical examination. They will report symptom score (standardized schema) on day 0, and 17. Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be stored anonymously. The trial will be monitored by extern resources.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •E.coli in blood culture
- •AND identical isolate in urine sample (>= 1.000 CFU) OR relevant clinical signs of UTI
排除标准
- •Bacterial infection origin from another organ (e.g. pneumonia)
- •Severe sepsis with multiorgan failure
- •Perinephritic abscess
- •Pyonephrosis requiring drainage
- •Allergy to pivmecillinam
- •E.coli isolate resistant to pivmecillinam
- •Pregnancy/breastfeeding
- •Severe neutropenia
- •Prostatitis
- •Severe kidney failure (eGFR<15 ml/min)
- •Using valproate
研究组 & 干预措施
Pivmecillinam
Patients treated with pivmecillinam
干预措施: pivmecillinam (Drug)
结局指标
主要结局
Clinical efficacy
时间窗: Day 17
Defined as abscence of fever, no need for other antibiotics than prescribed and improvement of symptoms (self-reported improvement and EQ 5D VAS-scale).
次要结局
- Readmission due to urinary tract infection (UTI)(Day 33)
- C-reactive protein-level (CRP)(Day 17)
- Adverse effects(Day 33)
- Microbial efficacy(Day 17)
- Readmission - any cause(Day 33)
研究者
Tore Stenstad
MD, PhD
Sykehuset i Vestfold HF