Complicated or recurrent urinary tract infections
Conditions
Interventions
Four sitafroxasin 50mg tablets are orally administrated one time daily (200 mg/day) for seven days.
Sponsors
Takehiro Iwata
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactIwata Takehiro
Okayama university hospital
Outcome results
None listed