Study of the clinical efficacy and number of days of administration of cefditoren pivoxil in the treatment of adult acute uncomplicated cystitis
- Conditions
- Adult acute uncomplicated cystitis
- Registration Number
- JPRN-UMIN000010449
- Lead Sponsor
- Okayama Urological Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 120
Not provided
1) Co-presence of another urinary tract infection in addition to acute uncomplicated cystitis. 2) Symptoms of urinary tract infection within 4 weeks prior to onset of the present infection. 3) Existence of systemic (diabetes mellitus, ongoing administration of an immunosuppressive agent, ongoing long-term administration of steroid, etc.) or local factors that might induce and/or promote a urinary tract infection. 4) Symptoms/findings have improved as a result of administration of another antimicrobial agent. 5) History of allergy, possibly due to cephem antibiotics. 6) A physical constitution that predisposes to development of bronchial asthma, rash, urticaria or other allergic symptoms. 7) Moderate or more severe renal dysfunction. 8) Women who are or may be pregnant, are breast-feeding, or desire to become pregnant during the study drug administration period. 9) Any other reason that the chief investigator judges as rendering a patient inappropriate for enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Bacteriological efficacy at 5~9 days after the completion of treatment. - Adverse events during the evaluation period (If causality cannot be denied: adverse drug reaction).
- Secondary Outcome Measures
Name Time Method - Clinical efficacy at 5~9 days after the completion of treatment. - Judgment of recurrence at 4~6 weeks after the completion of treatment.