Elderly patiens with pneumonia(including Nersing and healthcare-Associated Pneumonia,aspiration pneumonia)
Conditions
Interventions
Administration of sitafloxacin
Administration of garenoxacin
Sponsors
Nagasaki evaluation organization for clinical interventions
-Japan Community Health Care Organization Isahaya General Hospital -The Japanese Red Cross Nagasaki Genbaku Hospital -The Japanese Red Cros Nagasaki Genbaku Isahaya Hospital -Sasebo city General hospital -Sasebo Chuo Hospital -NHO Ureshino Medical center -Hokusho Central Hospital -Aino Memorial Hospital -National Hospital Nagasaki Medical Center -Izumikawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,The patient who acquired research participating consent by themselves (or Legally acceptable representative) by the document. 2,Acute infiltration are detected by chest X-ray or CT within the previous 48hours and the investigater suspects pneumonia from observation including at least one of the clinical symptoms/findings listed below -cough -Purulent sputum or increased purulence of sputum. -Abnormal findings on auscultation and percussion (including moist rales, percussion dullness, and decreased breath sounds). -Dyspnea or/and tachypnea -Fevre(axllary temprerature);37 degrees or more in body temprature Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count(<4,500/mm3) -Increase of CRP -Hypoxemia
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy at 5-10 days after completing administration.(TOC:Tset of cure) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Clinical efficacy 3 days after administration(early evaluation of drug efficacy) -Clinical efficacy at completion of administration(EOT:End of treatment) -Bacteriological response -Bacteriological response to causative bacteria bacterium -Bacteriological response to subject. -Safety | — |
Countries
Japan
Contacts
Public ContactTaiga Miyazaki, Yoshifumi Imamura
Nagasaki evaluation organization for clinical interventions office
Outcome results
None listed