Clinical trial NCT01937832: A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Community Acquired Pneumonia
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-10
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects


Eligibility criteria: Inclusion Criteria:

1. Patients aged between18\~73 years, either male or female
2. Patients requiring hospitalization or emergency room observation, and the need to receive intravenous antibiotic treatment
3. 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 IUDs).
4. Comply with the following clinical, radiological and microbiological criteria of Community-Acquired Pneumonia(CAP)
5. Patients had used ineffective systemic antimicrobial drugs before enrollment or had effective antimicrobial drugs within 72h before enrollment, used \<24h
6. Informed consent granted

Exclusion Criteria:

1. Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
2. Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacter baumannii;
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 secondary criteria (See Appendix);
7. Patients with a rapid progressive or end-stage disease, and can not survive until the end of the study period by antibiotic treatment;
8. Patients with bronchial obstruction or a history of obstructive pneumonia (not including 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 and pulmonary 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 years prior 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 upper limit of normal 10%;
16. 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% ;
17. Serious diseases that affecting the immune system, such as: a human immunodeficiency virus (HIV) infection history, or CD4 + T-lymphocyte count \<200/200/mm3, or Neutrophilic granulocytopenia (neutrophil count \<1500/mm3), or hematologic malignancies or solid organ or splenectomy, etc;
18. Patients who are taking steroid medications, at least 20mg daily dose of prednisone(or equivalent doses of other glucocorticoids);
19. 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;
20. Alcohol or illicit drug abuse history;
21. Patients who have accepted any other experimental drugs within 3 months prior to enrollment;
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 interference with clinical trials;

Primary outcomes:
measure: Per subject clinical cure rate
timeFrame: 7-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shiyan
country: China
facility: Taihe Hospital in Shiyan City
state: Hubei
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital ,Fudan University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
Study officials:
References: