A Phase IIIb, Randomized, Double-Blind, Multicenter, Parallel Group Study

INTERVENTION: Trade Name: Factive TM Product Name: Factive TM Pharmaceutical Form: Capsule* INN or Proposed INN: Gemifloxacin mesylate CAS Number: 204519‐65‐3 Current Sponsor code: Gemifloxacin mesylate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 320‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Mild to moderate community acquired bacterial pneumonia. ; MedDRA version: 7.0 Level: LLT Classification code 10010120 PRIMARY OUTCOME: Main Objective: To demonstrate that the clinical efficacy of oral gemifloxacin 320 mg once daily; for 5 days is at least as good as oral gemifloxacin 320 mg once daily for 7 days,; for the treatment of mild to moderate CAP.; Primary end point(s): Primary Efficacy Evaluation:; Clinical response (success or failure) at follow‐up is the primary efficacy; parameter.; For patients who were 'clinical successes' at end of therapy, the investigator will; review the clinical information obtained at the follow‐up evaluation, and will; evaluate each patient's clinical outcome as follows:; ; Follow‐Up Clinical Success: Sufficient improvement or resolution of signs and; symptoms of CAP for patients who were clinical successes at the end of therapy; visit, such that no additional antibacterial therapy is required for CAP.; ; Clinical Recurrence: Reappearance of signs and symptoms of CAP for patients; who were clinical successes at the end of therapy, such that additional; antibacterial therapy is required for CAP.; ; Unable to Determine: A valid assessment of clinical outcome could not be made; (e.g. the patient was lost to follow‐up or did not consent to a clinical; examination). Secondary Objective: To evaluate the safety of oral gemifloxacin 320 mg once daily for 5 days,; compared with oral gemifloxacin 320 mg once daily for 7 days, in patients with; mild to moderate CAP.; To evaluate the bacteriological efficacy of oral gemifloxacin 320 mg once daily; for 5 days, compared with oral gemifloxacin 320 mg once daily for 7 days, in; patients with mild to moderate CAP. INCLUSION CRITERIA: Male or female patients may be included in this study if the following criteria are met: 1. Patient is aged 18 years or more. 2. Patient has given written dated informed consent to participate in the study. 3. Patient has a clinical diagnosis of community acquired bacterial pneumonia characterised by fever (Fever defined as an oral temperature of 38°C or more, tympanic temperature of 38°C or more, or rectal temperature of 38.5°C or more) and at least two of the following signs and symptoms: _ ‐new or increased cough; _ ‐purulent sputum or a change in sputum characteristics; _ ‐auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, crackles on auscultation, bronchial breathing); _ ‐dyspnea; 4. Patients with a chest radiograph showing the presence of new or progressive infiltrate(s), consolidation, or pleural effusion consistent with pneumonia. 5. Patient is