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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01886053
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : June 25, 2013
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: Faropenem(high dose group) Drug: Faropenem(low-dose group) Drug: Ertapenem Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Ertapenem

Arm Intervention/treatment
Active Comparator: Ertapenem Drug: Ertapenem
dosage form: Injection dosage:1000 mg frequency: once a day

Experimental: Faropenem(low-dose group) Drug: Faropenem(low-dose group)
dosage form: Injection dosage:2400 mg frequency: twice a day

Experimental: Faropenem(high dose group) Drug: Faropenem(high dose group)
dosage form: Injection dosage:2400 mg frequency: Three times a day

Primary Outcome Measures :
  1. Per subject clinical cure rate [ Time Frame: 14-28 days ]
  2. Per subject microbiological cure rate [ Time Frame: 14-28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients aged between 18~70 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 intrauterine device).
  4. Comply with 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 72 h before enrollment, used <24 h
  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 methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
  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 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;
  18. Patients who are taking steroid medications, at least 20 mg 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 500 ml 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01886053

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China, Anhui
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
China, Guangdong
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
China, Hubei
Taihe Hospital in Shiyan City
Shiyan, Hubei, China, 442000
China, Jilin
The Second Hospital of Jilin University
Changchun, Jilin, China
China, Shandong
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266000
Huashan Hospital ,Fudan University
Shanghai, China, 200040
The Second Hospital of Tianjin Medical University
Tianjin, China, 300211
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Identifier: NCT01886053     History of Changes
Other Study ID Numbers: ZTDQ04104-CTF
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents