KCT0007669
Recruiting
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
ConditionsDiseases of the genitourinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the genitourinary system
- Sponsor
- Chosun University Hospital
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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