Comparative study of the efficacy and tolerance of intravenously administered azithromycin (1.5 g) given either as a single dose or over a 3 day period in patients with community-acquired pneumonia
- Conditions
- community aquired pneumonia
- Registration Number
- EUCTR2005-000105-65-AT
- Lead Sponsor
- Medical University of Vienna, Department of Internal Med. I, Division of Infectious Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
•Female or male, aged between 18 and 90 years, who achieve the criteria of risk classes II – IV after the scoring system of Bartlett et al. (Clin. Infectious Diseases 2000) (17).
•Written informed consent.
•Chest radiograph showing a new pulmonary infiltrate and two or more of the following clinical data: fever > 38°C, cough, dyspnea (respiratory rate over 20/min), elevated C-reactive protein or elvated (>10 G/L) or leukopenia (< 4 G/L) ,signs of consolidation on respiratory auscultation and a purulent sputum.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Pregnancy or lactation.
•Hemodialysis or hemofiltration.
•Impaired hepatic function with arised liver parameters.
•Allergy or hypersensitivity against study drugs.
•Nosocomial pneumonia
•Already hospitalized patients with pneumonia
•Severe asthma or cystic fibrosis
•Immunosuppression or asplenia
•Previous participation in a study in the last 6 weeks
•Known or suspected current infection that requires treatment with (an) additional anti-bacterial agent(s).
•Concurent medication like ergotamine, theophylline or digitalis.
•Achieving the criteria of risk group V after the scoring systemof Bartlett et.al.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method