pharyngitis, laryngitis, tonsillitis, acute bronchitis, pneumonia, middle ear infection, sinusitis
Conditions
Interventions
Administer 75mg of lascufloxacin 4 hours before the surgery (tissue resection)
Sponsors
Suzuki Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study; 1. Male and female aged 20 years or older at giving their consent 2. Patients who require tissue resection surgery in the following tissues with hospitalization (paranasal sinus mucosa (maxillary sinus mucosa, ethmoid sinus mucosa), middle ear mucosa, or palatine tonsil tissue) 3. Patients with indication of lascufloxacin 4. Patients who provide their consent in a written form by themselves from their free will after full explanation of the study from the responsible investigator and the understanding of the study
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in this study; 1. Patients with hypersensitivity or with history of severe side effects of quinolone antibacterial agents 2. Patients who are pregnant or possibly pregnant 3. Patients with severe hepatic or renal dysfunction 4. Patients with history of malignant tumor in the tissue which is planned to be resected, or patients with history of surgery in the tissue which is planned to be resected 5. Patients who were treated with quinolone antibacterial agents within 5 days before the administration of the study agent 6. Patients who are planned to be treated with the prohibited agents during the study period 7. Patients with habit of excess drinking or smoking 8. Patients with other conditions that the responsible investigator think inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of lascufloxacin 2. Concentration of lascufloxacin in each tissue (paranasal sinus mucosa (maxillary sinus mucosa, ethmoid sinus mucosa), middle ear mucosa, or palatine tonsil tissue) 3. Ratio of lascufloxacin concentration in each tissue (paranasal sinus mucosa (maxillary sinus mucosa, ethmoid sinus mucosa), middle ear mucosa, or palatine tonsil tissue) to plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events or diseases or the like | — |
Contacts
Public ContactKenji Suzuki
Yonaha Okanoue Hospital
Outcome results
None listed