Status:
COMPLETED
A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Community Acquired Pneumonia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects，and explore its therapeutic dose.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01886053
Start Date
April 1 2011
End Date
July 1 2012
Last Update
June 25 2013
Active Locations (9)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
3
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
4
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630