A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Per subject clinical cure rate [14-28 days]
- Per subject microbiological cure rate [14-28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
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Patients infected by pathogens methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
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Viral pneumonia;
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Aspiration pneumonia;
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Hospital-acquired pneumonia, including ventilator-associated pneumonia;
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Patients with Severe pneumonia who meet one primary criterion or three secondary criteria (See Appendix);
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Patients with a rapid progressive or end-stage disease, and can not survive until the end of the study period by antibiotic treatment;
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Patients with bronchial obstruction or a history of obstructive pneumonia (not including chronic obstructive pulmonary disease);
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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 ;
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Allergic to penem and carbapenem antibiotic;
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Pregnancy or lactation in women;
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Patients with uncontrolled psychiatric history or those at risk of suicide two years prior to enrollment;
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A history of epilepsy or other central nervous system disorders in patients;
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Patients with Renal dysfunction, screening serum creatinine values above the upper limit of normal 10%;
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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% ;
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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;
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Patients who are taking steroid medications, at least 20 mg daily dose of prednisone(or equivalent doses of other glucocorticoids);
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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;
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Alcohol or illicit drug abuse history;
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Patients who have accepted any other experimental drugs within 3 months prior to enrollment;
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more than 500 ml blood donation within 3 months prior to enrollment;
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Patients who have participated in this clinical trial ever before;
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Combined use of other antibacterial drugs in patients;
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Patients are diagnosed to have potential increased risks, or there may be interference with clinical trials;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Taihe Hospital in Shiyan City | Shiyan | Hubei | China | 442000 |
| 6 | The Second Hospital of Jilin University | Changchun | Jilin | China | |
| 7 | Qingdao Municipal Hospital | Qingdao | Shandong | China | 266000 |
| 8 | Huashan Hospital ,Fudan University | Shanghai | China | 200040 | |
| 9 | The Second Hospital of Tianjin Medical University | Tianjin | China | 300211 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZTDQ04104-CTF