Efficacy of sitafloxacin for urinary tract infection

JRCT ID: jRCTs061200052

Registered date:02/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Complicated or recurrent urinary tract infections
• Date of first enrollment: 07/04/2021
• Target sample size: 92
• Study type: Interventional
• Intervention(s): Four sitafroxasin 50mg tablets are orally administrated one time daily (200 mg/day) for seven days.

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takehiro Iwata