Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
- Conditions
- Pneumonia
- Registration Number
- JPRN-UMIN000008010
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(1) Patients with hypersensitivity to azithromycin, macrolide or ketolide antibiotic agents (2) Patients with hypersensitivity to levofloxacin or ofloxacin (3) Patients with liver dysfunction (AST, ALT, and total bilirubin > 3 times upper limit of normal range) (4) Patients with severe renal dysfunction (creatinine clearance <30 mL/min) (5) Patients with prior or current evidence of severe heart diseases (NYHA grade IV), congenital or sporadic prolongation of the QT interval, or receiving medications known to cause prolongation of the QT interval (6) Patients with severe underlying diseases or complications that have the difficulties of the evaluations of drug efficacy (7) Patients who require other systemic antibiotic treatments (8)Patients by whom other antimicrobial drugs (internal use or injection) were prescribed for the patient exceeding 48 hours to this infection before investigational new drug trial drug medication (9)Patients with gastrointestinal disorders disrupting drug absorption (10)Pregnant women or females with childbearing potential (11) Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction rates of serum IL-8 levels over time
- Secondary Outcome Measures
Name Time Method (1) Changes in biomarkers measured during treatment (2) Recovery rates of acquired pneumonia in each treatment group (3) Microbiological effective rates in each treatment group (4) Survival rates of patients on 30 days after each treatment (5) Evaluation of adverse events