NCT01886053已完成2 期
A Phase II Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 9
- 主要终点
- Per subject clinical cure rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
- •Patients infected by pathogens methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
- •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 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;
- •Patients who are taking steroid medications, at least 20 mg 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 500 ml 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;
研究组 & 干预措施
Ertapenem
Active Comparator
干预措施: Ertapenem (Drug)
Faropenem（low-dose group)
Experimental
干预措施: Faropenem（low-dose group) (Drug)
Faropenem（high dose group）
Experimental
干预措施: Faropenem（high dose group） (Drug)
结局指标
主要结局
Per subject clinical cure rate
时间窗: 14-28 days
Per subject microbiological cure rate
时间窗: 14-28 days
次要结局
未报告次要终点
研究者
研究点 (9)
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