The Efficacy of sitafloxacin in the elderly patients with pneumonia (included Nursing and Healthcare-Associated Pneumonia, aspiration pneumonia: NHCAP and aspiration pneumonia) ; a randomized controlled study of sitafroxacin and garenoxaci
- Conditions
- Elderly patiens with pneumonia(including Nersing and healthcare-Associated Pneumonia,aspiration pneumonia)
- Registration Number
- JPRN-UMIN000012627
- Lead Sponsor
- agasaki evaluation organization for clinical interventions
- Brief Summary
The clinical cure rates (primary efficacy endpoint) at test of cure (5-10 days after the end of treatment) in the per-protocol (PP) population of sitafloxacin and garenoxacin groups were 88.5% (95% confidence interval: 76.6-95.6) and 88.9% (95% confidence interval: 77.4-95.8), respectively (p=1.00).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1, Patients who are prohibited to take either sitafloxacin or garenoxacin. 2,Low body weight (less than 40 kg). 3, Severe renal dysfunction (Ccr is less than 30 mL/min, or eGFR is less than 30 mL/min). 4,Patients with history of convulsant disease such as epilepsy. 5,Patients who took quinolones for current pneumonia 6,Intake of azithromycin (zithromax ) within 7 days before starting this study. But the patients who get treated with low-dose macrolide can be included. 7,Patients with severe underlying diseases such as advanced cancer, primary lung cancer, metastatic lung cancer, severe heart failure and severe respiratory failure. 8,Patients with cystic fibrosis, AIDS, pneumocystis pneumonia, or active pulmonary tuberculosis. 9,Patients with pneumonia severity of PORT score V. 10,Patients whose participation in the study may put them at disadvantages.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method