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

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Faropenem
Ertapenem
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Anhui Provincial Hospital
  • The Third Affiliated Hospital of Sun Yat-sen University
  • Taihe Hospital in Shiyan City
  • The Second Hospital of Jilin University
  • Qingdao Municipal Hospital
  • Huashan Hospital ,Fudan University
  • The Second Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ertapenem

Faropenem

Arm Description

Outcomes

Primary Outcome Measures

Per subject clinical cure rate

Secondary Outcome Measures

Full Information

First Posted
September 4, 2013
Last Updated
September 4, 2013
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01937832
Brief Title
A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Official Title
A Phase III Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ertapenem
Arm Type
Active Comparator
Arm Title
Faropenem
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Faropenem
Intervention Description
dosage form: Injection dosage:1200 mg frequency: Three times a day
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
dosage form: Injection dosage:1000 mg frequency: once a day
Primary Outcome Measure Information:
Title
Per subject clinical cure rate
Time Frame
7-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between18~73 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 IUDs). Comply with the following 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 72h before enrollment, used <24h Informed consent granted Exclusion Criteria: Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria; Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacter baumannii; 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 CD4 + 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 20mg 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 500ml 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Ju Fang
Phone
13816357099
Email
Wujf53@gmail.com
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Taihe Hospital in Shiyan City
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Huashan Hospital ,Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Ju fang
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China

12. IPD Sharing Statement

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

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