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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.
ClinicalTrials.gov Identifier: NCT01886053
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date June 25, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • Per subject clinical cure rate [ Time Frame: 14-28 days ]
  • Per subject microbiological cure rate [ Time Frame: 14-28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Official Title  ICMJE A Phase II Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community Acquired Pneumonia
Intervention  ICMJE
  • Drug: Faropenem(high dose group)
    dosage form: Injection dosage:2400 mg frequency: Three times a day
  • Drug: Faropenem(low-dose group)
    dosage form: Injection dosage:2400 mg frequency: twice a day
  • Drug: Ertapenem
    dosage form: Injection dosage:1000 mg frequency: once a day
Study Arms  ICMJE
  • Active Comparator: Ertapenem
    Intervention: Drug: Ertapenem
  • Experimental: Faropenem(low-dose group)
    Intervention: Drug: Faropenem(low-dose group)
  • Experimental: Faropenem(high dose group)
    Intervention: Drug: Faropenem(high dose group)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2013)
189
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01886053
Other Study ID Numbers  ICMJE ZTDQ04104-CTF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor  ICMJE Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP