KCT0007669招募中未知
Evaluation of the clinical therapeutic effect of oral fosfomycin compared to the intravenous beta lactam/beta lactamase inhibitor or carbapenem in step-down treatment of patients with complicated urinary tract infection (cUTI) due to ESBL-producing enterobacteriaceae; A multicentre, randomized, prospective, open-label, non-inferiority trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male or Female, >18 years of age
- •2. Patients whose complicated urinary tract infection status is expected to require hospitalization and administration of parenteral antibiotics according to the judgment of the physician
- •3. Patients with definitive or suspected complicated urinary tract infection
- •- Patients with showing 2 or more symptoms or signs related to urinary tract infection of 1) and 2)
- •1) Chills, myalgia and febrile sense are present along with fever
- •; Fever observed and documented by the healthcare provider within 24 hours of screening (oral, tympanic, rectal temperature > 38°C)
- •2) dysuria, frequency, urgency, suprapubic pain or pelvic pain
- •3) there is evidence of pyuria or bacteriuria
- •- a. pyuria; Leukocyte esterase + or >8-10 WBC/HPF in urinalysis
- •- b. bacteriuria; Nitrite + or >1 organism/oil-immersion field in urinalysis
- •(Female) >105/mL, 2 consecutive times, clean catch midstream urine
- •(Male) >105/mL, 1 time, clean catch midstream urine
- •(Male, Female) >102-103/mL, 1 time (Catheter urine or urine within 48hr after catheter removal)
- •4) A person who has one or more of the following risk factors
- •- Anatomical or functional abnormalities of the genitourinary system
- •- Underlying diseases (diabetes, renal failure, polycystic nephropathy, kidney transplant, immunocompromised, etc.)
- •- Catheter-associated infection
- •- Infection by drug resistant strains
- •- Previous history of pyelonephritis
- •- Repeated antibiotic administration history
- •- Nosocomial infection
- •4. Patients who performed urine culture test (+/- blood culture test) at the time of screening
- •5. Patients whose pregnancy was excluded at the time of screening
- •- A woman with a negative urine human chorionic gonadotropin (hCG) test
- •6. Pateitns who was removed of implanted urinary devices (e.g., nephrostomy tubes, ureteric stents, etc.) within 24 hours of randomization or before or before randomization
- •7. Patients meeting all of the following randomization criteria
- •7-1) Urine culture test (+/- blood culture test) at the time of screening, Fosfomycin sensitivity (minimum inhibitory concentration [MIC] =32 mg/L, Europena Committe) within 3-7 days of starting empirical treatment on Antimicrobial Susceptibility [EUCAST] criteria) in patients with ESBL-producing enterobacteria
- •7-2) Patients who meet the criteria for improvement as a result of clinical/laboratory tests 3-7 days after starting empirical treatment
- •* Criteria for improvement of clinical/laboratory test results (at least 3 of the following must be satisfied including ?)
- •? Stable vital signs (systolic blood pressure=100, pulse<100)
- •? subsided fever
- •? Improvement or disappearance of symptoms related to urinary tract infection
- •? Improvement trend or normalization of leukocyte and C-reactive protein levels
- •? As a result of urine analysis, the improvement of pyuria or negative
- •- Leukocyte esterase negative or WBC per HPF decrease or negative
- •? As a result of urine analysis, the trend of improvement in bacteriuria or negative
- •- negative conversion of nitrite
- •- Or, strains less than 105/mL in the middle urine, less than 102/mL strains in the urine when Foley catheter is inserted)
排除标准
- •1. Patients with uncomplicated urinary tract infection
- •2. Patients with recent urinary tract or intrapelvic trauma
- •3. Those who have undergone urinary tract surgery within 7 days of randomization or planned urinary tract surgery during the study period
- •(Except for surgery or stent insertion or nephrostomy to relieve obstruction before the end of treatment)
- •4. Patients with complications of complicated urinary tract infection (eg, renal abscess, emphysema pyelonephritis, etc.) requiring treatment period of 10 days or more
- •5. Patients with non-renal co-infection such as endocarditis, osteomyelitis, meningitis, or pneumonia diagnosed within 7 days prior to randomization
- •6. Pregnant or breastfeeding women
- •7. Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times the upper limit of normal or total bilirubin more than twice the upper limit of normal at the time of screening
- •8. Patients with previous history of severe hypersensitivity or allergic reaction to Fosfomycin
- •9. Patients who, in the judgment of the healthcare provider, do not expect or do not agree to comply with the study protocol
- •10. Patients with other contraindications for oral fosfomycin administration
- •- Patients with severe renal failure (creatinine clearance less than 10mL/min)
- •- Hemodialysis patients
- •- There is a genetic problem such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, so intake of sucrose should be restricted. patient
研究者
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