High-dose Levofloxacin in Community-acquired Pneumonia
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000374
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
radiologic evidence of pneumonia on a chest x-ray and the presence of at least one of the followings: oral temperature greater than 38°C or less than 35.5°C, leukocytosis [white blood cell count (WBC) >10,000/mm3], or a high proportion of banded neutrophils more than 10%. Subjects were enrolled when they exhibited typical clinical signs and symptoms of pneumonia and were able to produce sputum samples.
suspected infection in areas other than the respiratory system; suspected intolerance to the experimental and control drugs; allergy to or severe side-effects from levofloxacin, azithromycin, ceftriaxone, quinolones, macrolides, or beta-lactams; hospital admission more than 2 weeks before the beginning of the study; receipt of intravenous antibiotics in the 24 h before enrollment; creatinine clearance less than 20 mL/min; empyema requiring chest drainage; chronic lung disease with impaired lung function; evidence of aspiration pneumonia; human immunodeficiency virus infection or immunosuppression (CD4+ cell count < 200/cm3); long-term tranquilizer use for treatment of epilepsy; co-morbidity likely to confound clinical evaluation; receipt of any drug for other clinical experiments within 30 days; pregnancy; and breast-feeding
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy: Clinical symptoms and signs, and radiologic findings
- Secondary Outcome Measures
Name Time Method Microbiologic evaluation;Tolerability and safety