A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Information source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Acquired Pneumonia
Intervention: Faropenem (Drug); Ertapenem (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd Overall contact:
Wu Ju Fang, Phone: 13816357099, Email: Wujf53@gmail.com
Summary
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in
community-acquired pneumonia (CAP) subjects
Clinical Details
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Per subject clinical cure rate
Eligibility
Minimum age: 18 Years.
Maximum age: 73 Years.
Gender(s): Both.
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;
Locations and Contacts
Wu Ju Fang, Phone: 13816357099, Email: Wujf53@gmail.com
Huashan Hospital ,Fudan University, Shanghai 200040, China; Not yet recruiting
Wu Ju fang, Sub-Investigator
The Second Hospital of Tianjin Medical University, Tianjin 300211, China; Not yet recruiting
Anhui Provincial Hospital, Hefei, Anhui 230001, China; Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China; Not yet recruiting
Taihe Hospital in Shiyan City, Shiyan, Hubei 442000, China; Not yet recruiting
The Second Hospital of Jilin University, Changchun, Jilin, China; Not yet recruiting
Qingdao Municipal Hospital, Qingdao, Shandong 266000, China; Not yet recruiting
Additional Information
Starting date: October 2013
Last updated: September 4, 2013
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