Efficacy of sitafloxacin for urinary tract infectio
- Conditions
- Complicated or recurrent urinary tract infections
- Registration Number
- JPRN-jRCTs061200052
- Lead Sponsor
- Takehiro Iwata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 92
Aged 20 years and over and fever >=37.5 degree centigrade with any urinary tract infection symptoms, such as costovertebral angel tenderness, micturition pain, urinary frequency, urgency or lower abdominal pain with pyuria. Pyuria was defined as: >=10 white blood cells (WBCs)/mL counted by flow cytometric analysis; >=10 WBCs/mm3 counted by counting chamber or a positive leucocyte esterase result using urine test paper with uncentrifuged urine; or .5 WBCs/high-power field in the sediment of centrifuged urine.
The patints who were diagnosed as complicated cystitis or recurrent cystitis or pyelonephritis or prostatitis or epididymitis.
Patients who had a previous episode of quinolone hypersensitivity, who had allergic asthma or hives; immunosuppression; spastic diseases such as epilepsy; myasthenia gravis; aortic dissection; current pregnancy; renal failure, who are or will be pregnant.
Viable cell count before start of medication <10 ^ 5 CFU / mL.
Patients who have urethral catheterization or intermittent catheterization.
Patients who were judged as ineligible for this study by the investigators because of low compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was the microbiological outcome 5-9 days after the end of administration; effectiveness was defined as a negative urine culture (<104CFU mL).
- Secondary Outcome Measures
Name Time Method The secondary endpoints were the clinical outcome 5-9 days and 4-6 weeks after the treatment completion; a clinical cure was defined as the absence of symptoms. The other secondary endpoints were adverse effects.