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A Phase III 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.
 
ClinicalTrials.gov Identifier: NCT01937832
Recruitment Status : Unknown
Verified September 2013 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
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

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: Faropenem Drug: Ertapenem Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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

Experimental: Faropenem Drug: Faropenem
dosage form: Injection dosage:1200 mg frequency: Three times a day




Primary Outcome Measures :
  1. Per subject clinical cure rate [ Time Frame: 7-14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

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 ClinicalTrials.gov identifier (NCT number): NCT01937832


Contacts
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Contact: Wu Ju Fang 13816357099 Wujf53@gmail.com

Locations
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China, Anhui
Anhui Provincial Hospital Not yet recruiting
Hefei, Anhui, China, 230001
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510630
China, Hubei
Taihe Hospital in Shiyan City Not yet recruiting
Shiyan, Hubei, China, 442000
China, Jilin
The Second Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China
China, Shandong
Qingdao Municipal Hospital Not yet recruiting
Qingdao, Shandong, China, 266000
China
Huashan Hospital ,Fudan University Not yet recruiting
Shanghai, China, 200040
Sub-Investigator: Wu Ju fang         
The Second Hospital of Tianjin Medical University Not yet recruiting
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.
ClinicalTrials.gov Identifier: NCT01937832     History of Changes
Other Study ID Numbers: CTTQ04104-3-CTF
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Ertapenem
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents