Open-label randomized comparative study of cefotiam vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia

INTERVENTION: cefotiam 1g IV, every 12 hrs, for 4‐14 days. Clarithromycin 200mg PO, bid, for 4‐14 days. May be adjusted when renal failure. ampicillin/sulbactam 3g IV, every 12 hrs, for 4‐14 days. Clarithromycin 200mg PO, bid, for 4‐14 days. May be adjusted when renal failure. CONDITION: Community‐acquired pneumonia PRIMARY OUTCOME: Clinical response at the end of therapy, days 11‐14 SECONDARY OUTCOME: Early clinical response at days 4 and 7; Bacteriological response at days 11‐14 (in bacteriologically evaluable patients); Survival at day 30 INCLUSION CRITERIA: (1) Patients with community‐acquired pneumonia aged 15 yrs or more (2) Radiological appearance of a new and/or progressive pulmonary infiltrate(s) (3) At least two of the followings: cough, sputum or change of sputum character (increased volume and/or purulence), dyspnea, tachypnea, abnormal breathing sound (wheeze etc.), pleuritic chest pain, auscultatory findings on chest examination consistent with the lung infiltrate, documented axillary body temperature > or = 37.5C within the past 24hrs, rigors and/or chills, general malaise, and a WBC count of > or = 10,000/mm3 or < 3,000/mm3.