A Phase 2, Multi-dose, Double-blind, Active-controlled, Randomized Study to evlauate the safety, efficacy and Pharmacokinetic profile of Zabofloxacin at three dose regimens for patients with mild to moderate Community Acquired Pneumonia

Dong Hwa Pharm0 个研究点目标入组 108 人开始时间: 待定最近更新: 2019年3月11日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 108

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 18(Year) 至 o Limit（—）
性别: All

入选标准

•Male or female > 18 years old
•Subject who is in ambulatory care unit and suitable for oral treatment of CAP.
•Subject who is Risk Score < 91 (I, II and II class)
•Subject who is confirmed of pneumonia through PA/lateral X-ray within 48 hours prior to treatment (New infiltrate or consolidation was confirmed which cannot attribute to any process other than pneumonia).
•Subject who has a fever (>37.8 °C at oral or tympanic or >38.1°C at rectal).
•Subject who is difficult in breathing.
•Clinical diagnosis of pneumonia is demonstrated by at least 2 of the followings:
•- new or worsened cough
•- production of purulent sputum or a change in the character of sputum
•- ausculatory findings of rales and/or evidence of pulmonary consolidation on pulmonary examination (e.g. bronchial respiration sounds, dullness on percussion)
•Woman who is able to be pregnant should be negative in urine pregnancy test (ß-hCG) result before randomization and should agree to have appropriate contraception during the study. However, hormonal contraception alone for birth control is not appropriate to use.
•Subject who is able to give written informed consent before study starting in a approved manner by the Institutional Review Board or Ethics Committee (EC) and comply with the requirements of the study.

排除标准

•Has more than one day treatment of any systemic or inhaled antibiotic within the last 10 days
•Has previous diagnosed condition of infectious disease or the complication in the course of infectious disease (e.g., septic shock, bronchiectasis, lung abscess or emphysema, aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis, postobstructive pneumonia, etc.).
•Is life-threatening or serious unstable medical condition.
•Is hospitalized or has hospital acquired infection within the previous 30 days.
•Is resident in a long-term care facility.
•Is a Chronic Hepatitis B carrier.
•Has any evidence of, or a known carrier of Hepatitis C antibody.
•Has the presence of renal or hepatic disease meeting any of the followings:
•- Creatinine Clearance < 50 mL/min
•- BUN > 30 mg/dl
•- ALT or AST > 3 x ULN
•- Total bilirubin > 2 x ULN
•- Alkaline phosphatase > 1.25 x ULN.
•Is currently abnormal malabsorption status (e.g., short bowel syndrome, active crohn’s disease, celiac disease, etc.)
•Is a neutropenia patient with absolute neutrophil count < 1000/mm3. In case, absolute neutrophil count is low as 500cells/mm3, the subject could be enrolled only if the value was dropped due to an acute infection.
•Is platelet count < 75,000/mm3. In case, platelet count is as low as 50,000 /mm3, the subject could be enrolled only if it was stable considering the previous medical history.
•Is coagulation tests > 1.5 x ULN (PT, PTT, or INR). In case, anticoagulants are > 1.5 x ULN, the subject could be enrolled, only if these values were stable and within the therapeutic range.
•Has immunocompromised illness such as HIV-positive or AIDS, organ (bone marrow) transplant recipients, hematological malignancy, etc.
•Has Immunosuppressive therapy of chronic use of corticosteroids (e.g., > 20 mg prednisone or equivalent per day for = 14 days).
•Has history of alcohol or drug abuse within the last 2 years.
•Has convulsion history and is taking anti-convulsive medication within 1 year or had convulsion history within 1 year.
•Has history of ventricular arrhythmia.
•Has history of QTc prolongation. (e.g., > 450msec)
•Is pregnant or nursing woman, or does not use medically effective method of contraception in childbearing potential women (e.g., condom, oral contraception, intrauterine device, sexual abstinence, etc.).
•Participated in any investigational drug or device study within 30 days prior to this study entry.
•Has received zabofloxacin in a clinical trial previously.
•Has history of hypersensitivity to fluoroquinolones.
•In the opinion of investigator, the current condition or abnormality would compromise the safety of the subject or the quality of the data.
•Needs to take medication to reduce convulsion.
•Needs to take medication to prolong QTc interval.
•Needs to take systemic or inhaled antibiotic combination therapy.
•Needs to take long-term antibiotic for 7 days or more

研究者

发起方

Dong Hwa Pharm

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