acute rhinosinusitis
Conditions
Interventions
Sitafloxacin Tablets 50 mg (200mg/day)
Sponsors
Wakayama-Okayama Otolaryngology Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 16 years or older (2) Male or Female (3)Diagnosed as moderate or severe in the clinical severity (4) Patients who fulfill all following criteria at the start of the medication or 1day before and determined to be bacterial infectious disease. (a)Purulent or mucopurulent rhinorrhea or postnasal drip (b)Facial pressure or facial pain / frontal headache
Exclusion criteria
Exclusion criteria: (1)Patients with history of hypersensitivity to quinolone (2) Patients with history of convulsive disorder (e.g. Epilepsy) (3)Pregnant or lactating women (4)Severe heart diseases or hepatic dysfunction (5) Moderate or severe renal dysfunction (6) Severe underlying disease; patients in which clinical evaluation is difficult because of confounding diseases (7) Patients showing improvement of symptoms by the other antibiotic therapy (8) Administration of Sitafloxacin 7 days before starting Sitafloxacin (9)For other reasons, patients determined to be inappropriate for study entry by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy judged by the scoring system at the end of the medication or at the end of observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological efficacy at the end of the medication or at the end of observation period | — |
Countries
Japan
Contacts
Public ContactDaisuke Fukuta
Wakayama-Okayama Otolaryngology Pharma secretariat
Outcome results
None listed