EUCTR2016-004486-37-NL进行中（未招募）1 期
FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment - FORECAST
niversity Medical Centre Utrecht0 个研究点开始时间: 2017年8月14日最近更新:
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
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
- Female
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: fever or low temperature (=38.0 C ? or <36 C ?), rigors, delirium or hemodynamic instability as a result of sepsis requiring intravenous fluids 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). The local study investigator determines the presumptive diagnosis as the primary reason for hospitalisation 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 = 105 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.
- •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 100
排除标准
- •-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 /µl), paraplegia, long-term indwelling catheters (placed =24 hours before admission), urostomy, ileal loops, 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
研究者
相似试验
已完成
3 期
FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown TreatmentComplicated urinary tract infectionascending urinary tract infection10004018NL-OMON47265niversitair Medisch Centrum Utrecht240
已完成
不适用
FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown TreatmentKeywords:-Fosfomycin-Urinary Tract Infection-Enterobacteriaceae-Antibiotic therapyNL-OMON22782niversity Medical Center, Utrecht240
进行中（未招募）
1 期
Clinical trial for the treatment of febrile neutropenia in hematologic patients with antibiotics: fosfomycin versus ciprofloxacin.Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction, autologous or allogeneic hematopoietic stem cell transplantation.MedDRA version: 21.0Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10076734Term: Chemotherapy induced neutropeniaSystem Organ Class: 100000004851MedDRA version: 22.0Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 100000004865EUCTR2021-000354-25-ESFINBA156
进行中（未招募）
不适用
Randomized controlled trial of the efficacy of fosfomycin vs ciprofloxacin as antibiotic prophylaxis before transrectal ultrasound guided prostateurinary sepsisEUCTR2012-001031-31-ESFundación para Formación e Investigación Sanitaria
已完成
3 期
Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibioticsColorectal tumor with planned elective laparoscopic resectionJPRN-UMIN000000776The Japan-Multinational Trial Organization(JMTO)580