Adult acute uncomplicated cystitis
Conditions
Interventions
Cefditoren pivoxil (trade name: Meiact MS Tablets 100 mg) will be orally administered at 1 tablet, 3 times per day, for 3 days.
Cefditoren pivoxil will be orally administered at 1 tablet, 3 times per
Sponsors
Okayama Urological Research Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Symptoms A body temperature of <37.5 degree Centigrade, with any of the following subjective symptoms: micturition pain, frequent urination, urinary urgency or lower abdominal pain. 2) Pyuria Presence of pyuria prior to the start of treatment, meeting any of the following criteria: - Using primitive urine, >=10 WBC/microL by flow cytometry or >=10 WBC/mm3 when using a counting chamber - Using primitive urine, a positive test for esterase: - Microscopic examination of urine sediment: >=5 WBC/hpf
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - Clinical efficacy at 5~9 days after the completion of treatment. - Judgment of recurrence at 4~6 weeks after the completion of treatment. | — |
Countries
Japan
Contacts
Public ContactKoichiro Wada
Okayama University Hospital Department of Urology
Outcome results
None listed