Pneumonia
Conditions
Interventions
Treatment group: Sequential administration of beta-lactam plus azithromycin (500 mg for 120 min). Treatment to be continued if there was no improvement in inflammatory responses and radiological f
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Patient with be from 16 to 85-years old (2) Moderate to severe pneumonia patents that needed to be hospitalized (3) Patient without long-term oral steroid treatment (4) Patients who are agreed with the study enrollment
Exclusion criteria
Exclusion criteria: Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rates of serum IL-8 levels over time | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactMasaharu Shinkai
Yokohama City University Medical Center Respiratory Disease Center
Outcome results
None listed