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

Inclusion Criteria:

1. Patients aged between18~73 years, either male or female

2. Patients requiring hospitalization or emergency room observation, and the need toreceive intravenous antibiotic treatment

3. Women of childbearing age having negative pregnancy test at the time of enrollment andagreeing to take effective contraceptive measures from the delivery to 7 ~14 daysafter stopping .(for example: oral contraception, injectable contraception, or implantcontraception , spermicides and condoms, or IUDs).

4. Comply with the following clinical, radiological and microbiological criteria ofCommunity-Acquired Pneumonia(CAP)

5. Patients had used ineffective systemic antimicrobial drugs before enrollment or hadeffective antimicrobial drugs within 72h before enrollment, used <24h

6. Informed consent granted

Exclusion Criteria:

1. Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydiapneumoniae, Legionella pneumophila bacteria;

2. Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacterbaumannii;

3. Viral pneumonia;

4. Aspiration pneumonia;

5. Hospital-acquired pneumonia, including ventilator-associated pneumonia;

6. Patients with Severe pneumonia who meet one primary criterion or three secondarycriteria (See Appendix);

7. Patients with a rapid progressive or end-stage disease, and can not survive until theend of the study period by antibiotic treatment;

8. Patients with bronchial obstruction or a history of obstructive pneumonia (notincluding chronic obstructive pulmonary disease);

9. 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 andpulmonary vasculitis;

10. Infections acquired from hospitals, nursing homes or other long-term care facilities,or patients hospitalized within 14 days prior to enrollment ;

11. Allergic to penem and carbapenem antibiotic;

12. Pregnancy or lactation in women;

13. Patients with uncontrolled psychiatric history or those at risk of suicide two yearsprior to enrollment;

14. A history of epilepsy or other central nervous system disorders in patients;

15. Patients with Renal dysfunction, screening serum creatinine values above the upperlimit of normal 10%;

16. The Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3times the upper limit of the reference value, or total bilirubin beyond the upperlimit of the normal range by 10% ;

17. Serious diseases that affecting the immune system, such as: a human immunodeficiencyvirus (HIV) infection history, or CD4 + T-lymphocyte count <200/200/mm3, orNeutrophilic granulocytopenia (neutrophil count <1500/mm3), or hematologicmalignancies or solid organ or splenectomy, etc;

18. Patients who are taking steroid medications, at least 20mg daily dose of prednisone(orequivalent doses of other glucocorticoids);

19. Patients who are accepting chemotherapy drug therapy or anti-cancer therapy, or planto accept such treatment during the trial six months prior to enrollment;

20. Alcohol or illicit drug abuse history;

21. Patients who have accepted any other experimental drugs within 3 months prior toenrollment;

22. more than 500ml blood donation within 3 months prior to enrollment;

23. Patients who have participated in this clinical trial ever before;

24. Combined use of other antibacterial drugs in patients;

25. Patients are diagnosed to have potential increased risks, or there may be interferencewith clinical trials;