Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 10 Days Versus Clarithromycin in the Treatment of Community-Acquired Pneumonia”

INTERVENTION: Product Name: Faropenem medoxomil Product Code: REP319740 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Faropenem medoxomil CAS Number: 141702‐36‐5 Current Sponsor code: REP319740 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐mg Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Klaricid XL Product Name: clarithromycin Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: clarithromycin CAS Number: 81103119 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 500‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Community‐acquired pneumonia. This disease can be defined as an acute lower respiratory tract infection not acquired in a hospital or a long‐term care facility. ; MedDRA version: 9.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia PRIMARY OUTCOME: Main Objective: ‐ To demonstrate the efficacy of faropenem medoxomil by establishing its non‐ inferiority to clarithromycin, in terms of clinical response rate, in the treatment of patients with CAP (community‐acquired pneumonia) in the ITT (Intent to Treat) and modified Intent to Treat subjects mITT (modified Intent to Treat) populations; ‐ To evaluate the safety and tolerability profile of faropenem medoxomil 600 mg PO BID for 10 days in patients with CAP (community‐acquired pneumonia) Primary end point(s): The primary analyses will be the comparison of the clinical response rates of faropenem medoxomil to clarithromycin at the Test‐of‐Cure visit in the ITT (Intent to Treat ) and mITT (modified Intent to Treat) Populations.; A comparison of the incidence of adverse events for faropenem medoxomil and clarithromycin in the Intent‐to‐Treat (safety) Population.; ; Secondary Objective: • To demonstrate the efficacy of faropenem medoxomil by establishing its non‐inferiority to clarithromycin, in terms of clinical response rate, in the treatment of subjects with CAP in the CE and ME Populations; • To demonstrate the efficacy of faropenem medoxomil by establishing its non‐inferiority to clarithromycin, in terms of bacteriological response rate, in the treatment of subjects in the mITT and ME (Microbiologically Evaluable) Populations; INCLUSION CRITERIA: 1. Male or non‐pregnant female 18 years of age or older 2. Subjects with fever documented within the past 24 hours (PO >38oC/100.4oF; Axillary >37.5oC/99.5oF; TM or Rectal >38.5oC/101.2oF) 3. Subjects who can produce an adequate (i.e., sputum Gram stain with >25 PMNs/LPF and <10 squamous epithelial cells/LPF) and purulent (i.e., cloudy and discolored) sputum specimen 4. A CXR obtained within 24 hours prior to initiating IP therapy and showing the presence of a new or progressive pulmonary infiltrate(s) 5. The presence of one (1) or more of the following clinical findings: • New or increased cough • Dyspnea or tachypnea (RR > 20 breaths per minute [bpm] but = 30), particularly if progressive in nature • Pleuritic chest pain • Auscultatory findings on pulmonary examination of rales/rhonchi and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) 6. Subjects who are able to take oral m