EUCTR2020-005738-13-SE进行中（未招募）1 期
Pivmecillinam with Amoxicillin/clavulanic acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Region Skåne
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All 6 of the following criteria must exist for inclusion to be made.
- •Adult men and women (> 18 years) with urine and/or blood culture positive for EPE. Thus, intravenous antibiotics must have been started for patients to be included.
- •Patient has received in patient care with 1-5 days of intravenous treatment with empirical antibiotics. The treating physician has considered per oral treatment safe.
- •fever (= 38.0 C at least once at home or at hospital) at the emergency room (ER). Per oral therapy can be initiated regardless of temperature.
- •clinical suspicion of UTI at the ER. The latter is suspected due to at least one of the following symptoms:
- •-flank pain
- •-positive dipstick analysis
- •-percussion tenderness over kidneys
- •informed consent is signed by patient.
- •discontinuing parenteral treatment and starting treatment with per oral antibiotics is considered safe according to treating physician.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •known/suspected beta-lactam allergy.
- •clinical isolate of EPE is pivmecillinam-resistant
- •Other reason, according to treating physician, to which patient is unfit to be included in the study.
研究者
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