NL-OMON47265已完成3 期
FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment - FORECAST FORECAST-ECO (substudy) FORECAST-FAR (substudy)
niversitair Medisch Centrum Utrecht0 个研究点目标入组 240 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Hospitalised
- •-Competent women (*18 years), able to give informed consent
- •-AF-UTI as presumptive diagnosis and primary reason for hospitalisation*
- •-Adequate intravenous antibiotic therapy for *48 - *120 hours**
- •-Candidate for safe iv to oral switch as judged by the attending physician
- •-Urine (*104 CFU/ml) OR blood culture obtained within 24 hours before or after admission: Escherichia coli , ciprofloxacin S AND fosfomycin S***;* Acute Febrile Urinary Tract Infections (AF-UTI) are UTI with at least one of the forthcoming systemic symptoms/signs: fever or low temperature (*38.0 C * or <36 C *), rigors, delirium or hemodynamic instability as a result of sepsis requiring intravenous fluids, increase in CRP (*30mg/L) or leucocytes (*10*109/L) AND at least one of the following local symptoms: lower abdominal pain, low back pain, flank pain or costo-vertebral angle pain or tenderness on physical examination, any of the following symptoms of UTI (dysuria, urinary urgency, urinary frequency, suprapubic/pelvic discomfort, macroscopic hematuria, new urinary incontinence or worsening of pre-existing incontinence). Local symptoms are not required in case the urine and blood culture are positive for a phenotypically matched E.coli. The local study investigator determines the presumptive diagnosis as the primary reason for hospitalization with consultation of the attending physician.
- •**Amoxicillin+/-clavulanic acid / 2nd or 3rd cephalosporin/ aminoglycoside/ carbapenem/ fluoroquinolones/ trimethoprim-sulfamethoxazole OR a combination AND in vitro susceptibility of the causative E.coli to at least one of the used agents
- •*** If a participating microbiological laboratory only processes urine cultures * 10*5 CFU/ml, only these will be included. If an urine or blood culture results in another non-E.coli bacteria that requires antibiotic treatment, the patient should be excluded. In case of presence of non- E.coli-type Enterobacteriaceae in urine culture (*103 CFU/ml), the patient should be excluded automatically.;FORECAST-FAR/ECO: All participants that are eligible for the FORECAST study, are automatically eligible for the FAR and ECO substudy.
排除标准
- •Exclusion criteria
- •-Pregnant or nursing women
- •-Glomerular filtration rate < 30 ml/min/1,73 m3 or renal replacement therapy
- •-Concomitant systemic antibacterial treatment #
- •-Ascertained or presumptive hypersensitivity to the active compounds and/or any excipient of the products or to any quinole
- •-Participation to any trial with an investigational product involved in the 30 days before the screening visit
- •-Every other laboratory result, clinical condition, disease or treatment that, in investigator*s opinion, make the subject non suitable for the study
- •-Specific comorbidity or diagnosis##
- •-Contraindications/interactions for any of the active compounds or medication ###
- •-Patients with inadequate understanding of the study risks or its requirements or unwilling to plan a follow-up visit;# If prophylactic antibiotic therapy could not be paused during study therapy, the patient should be excluded Except for continuation of prophylactic antibacterial therapy
- •## Renal transplant patients, polycystic kidney disease, neutropenia (<500 /*l), paraplegia, long-term indwelling catheters, (placed *24 hours before admission), urostomy, ileal loops, suspicion/presence of renal abscess, suspicion of septic metastatic foci/endocarditis, long-term urinary catheter (placed *24 hours before admission), e.g. double-J catheter, nephrostomy catheter, suprapubic catheter, suspicion/presence of renal abscess, suspicion of septic metastatic foci/endocarditis
- •### Concurrent use of Tizanidin, Clozapin or Theophylline. If pausing or conversion of this medicine disadvantages the participant, she will be excluded. Patients with a history of tendon disease/disorder related to quinolone treatment. Patients with known risk factors for prolongation of the QT interval. Glucose-6-phosphate dehydrogenase deficiency
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