community aquired pneumonia
Conditions
Interventions
Trade Name: Zithromax i.v.
Product Name: Zithromax
Pharmaceutical Form: Injection*
Sponsors
Medical University of Vienna, Department of Internal Med. I, Division of Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and tolerability of intravenously administered azithromycin given as a 1.5 g single dose compared to 500 mg daily dose over a period of 3 days in patients suffering from community-acquired pneumonia. If azithromycin treatment administered intavenously as a 1.5 g dose can be proven therapeutically equivalent or not inferior to 500 mg administered intravenously over a period of 3 days, treatment of CAP patients can be optimised. This short regimen has the potential for enhancement of patient compliance and will lead to a reduction of costs because of minimisation of hospitalisation days. It even provides the possibility of outpatient treatment administration in patients with minor compliance. ;Secondary Objective: Microbiological cure/failure, frequency of adverse events, death, additionally required therapeutic measures and dynamics of x-ray findings will be evaluated ;Primary end point(s): For the evaluation of clinical efficacy, outcome is defined as clinical cure, failure or indeterminate. Efficacy will be evaluated in both study groups. | — |
Countries
Austria
Outcome results
None listed