Community acquired pneumonia
Conditions
Interventions
Administration of moxifloxacin.
Administration of garenoxacin.
Sponsors
Nagasaki evaluation organization for clinical interventions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who are 20 years of age or more. 2.Acute infiltrative changes are detected by chest X-ray or CT within the previous 48 hours and the investigator suspects community acquired pneumonia from observation including at least one of the clinical symptoms/findings listed below: 1)Cough. 2)Purulent sputum or increased purulence of sputum. 3)Abnormal findings on auscultation (including moist rales, dull breath sounds, and decreased breath sounds). 4)Dyspnea or/and tachypnea. 5)Fever (axillary temperature): >=37 degrees Celsius. 6)Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count (<4,500/mm3). 7)Increase of CRP. 8)Hypoxemia. 3.Community acquired pneumonia with severity of PORT score I-IV (mild to moderate). 4.Patients who give their consent to participation in the study. 5.Patients who are able to take oral medications. 6.Patients, who took other medicine (except quinolones) more than 3 days and did not have any improvements, can participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patients who are prohibited to take either moxifloxacin 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.Patients with episodes of apparent aspiration. 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 response at the test-of-cure (TOC) visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response at the 3rd day after the initiation of the treatment. 2. Clinical response at the end-of-treatment (EOT). 3. Bacteriological response at EOT. 4. Safety of drugs. | — |
Countries
Japan
Outcome results
None listed