None listed
Conditions
Interventions
Drug : Oral Administration of Zabofloxacin Hydrochloride 300mg, Zabofloxacin Hydrochloride 400mg, Moxifloxacin Tablet 400mg, Zabofloxacin Capsule Placebo and Moxifloxacin Tablet Placebo Double Dummy
Sponsors
Dong Hwa Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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.
Exclusion criteria
Exclusion criteria: • 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response rate of Cure at the TOC(Test of Cure) Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response rate of cure at the EOS(End of Study) Visit;Microbiological Response rate at the TOC(Test Of Cure) in the Bacteriological PP(Per Protocol) and ITT(Intent To Treat) poppulation;Clinical Response rate of cure at the TOC(Test Of Cure) Visit in the Bacteriological PP(Per Protocol) and ITT(Intent To Treat) poppulation;Time to decrease in baseline signs and symptoms in the clinical PP(Per Protocol) and ITT(Intent To Treat) poppulation;Microbiological Response rate of eradication at the EOS(End Of Study) Visit in the Bacteriological PP(Per Protocol) and ITT(Intent To Treat) poppulation | — |
Countries
Korea, Republic of
Contacts
Public ContactYangsoo Kim
Asan Medical Center
Outcome results
None listed