A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia

Inclusion criteria

• Patients aged between 18~70 years, either male or female
• Patients requiring hospitalization or emergency room observation, and the need to receive intravenous antibiotic treatment
• Women of childbearing age having negative pregnancy test at the time of enrollment and agreeing to take effective contraceptive measures from the delivery to 7 ~14 days after stopping .(for example: oral contraception, injectable contraception, or implant contraception , spermicides and condoms, or intrauterine device).
• Comply with clinical, radiological and microbiological criteria of Community-Acquired Pneumonia(CAP):
• Patients had used ineffective systemic antimicrobial drugs before enrollment or had effective antimicrobial drugs within 72 h before enrollment, used <24 h
• Informed consent granted

Exclusion criteria

• Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
• Patients infected by pathogens methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
• Viral pneumonia;
• Aspiration pneumonia;
• Hospital-acquired pneumonia, including ventilator-associated pneumonia;
• Patients with Severe pneumonia who meet one primary criterion or three secondary criteria (See Appendix);
• Patients with a rapid progressive or end-stage disease, and can not survive until the end of the study period by antibiotic treatment;
• Patients with bronchial obstruction or a history of obstructive pneumonia (not including chronic obstructive pulmonary disease);
• Suffering from any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil infiltration disease and pulmonary vasculitis;
• Infections acquired from hospitals, nursing homes or other long-term care facilities, or patients hospitalized within 14 days prior to enrollment ;
• Allergic to penem and carbapenem antibiotic;
• Pregnancy or lactation in women;
• Patients with uncontrolled psychiatric history or those at risk of suicide two years prior to enrollment;
• A history of epilepsy or other central nervous system disorders in patients;
• Patients with Renal dysfunction, screening serum creatinine values above the upper limit of normal 10%;
• The Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times the upper limit of the reference value, or total bilirubin beyond the upper limit of the normal range by 10% ;
• Serious diseases that affecting the immune system, such as: a human immunodeficiency virus (HIV) infection history, or cluster of differentiation 4 + T-lymphocyte count <200/200/mm3, or Neutrophilic granulocytopenia (neutrophil count <1500/mm3), or hematologic malignancies or solid organ or splenectomy, etc;
• Patients who are taking steroid medications, at least 20 mg daily dose of prednisone(or equivalent doses of other glucocorticoids);
• Patients who are accepting chemotherapy drug therapy or anti-cancer therapy, or plan to accept such treatment during the trial six months prior to enrollment;
• Alcohol or illicit drug abuse history;
• Patients who have accepted any other experimental drugs within 3 months prior to enrollment;
• more than 500 ml blood donation within 3 months prior to enrollment;
• Patients who have participated in this clinical trial ever before;
• Combined use of other antibacterial drugs in patients;
• Patients are diagnosed to have potential increased risks, or there may be interference with clinical trials;