The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
600 mg/tablet, oral administration of a single tablet.
500 mg/tablet, oral administration of a tablet daily.
Placebo of levofloxacin hydrochloride tablet, without active components.
Nei Mongo medical University
Nei Mongo, China
RECRUITINGTo evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis.
1. Clinical efficacy: consists of clinical evaluation which expressed as clinical cure and clinical failure. 2. Bacteriological efficacy: consists of eradication, supposed eradication, persistence, supposed persistence, partial eradication,; 3. Comprehensive therapeutic efficacy: consists of cure and failure
Time frame: 7-10 days
safety of treatment
Vital signs, ECG, laboratory examinations and adverse events.
Time frame: 7-10 days
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Placebo of prulifloxacin film-coated tablet without active components.