None listed
Conditions
Interventions
Endovenous tigecycline will be administered for a minimum of 3 days and a maximum of 14 days.
Group name:levofloxacin Type of group
Intravenous levofloxacin will be administered for a minimum of 3 days and a maximum of 14 days.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female or male patients 18 years of age or older. 2. Patients hospitalized for an episode of pneumonia acquired in the community that require IV antibiotic treatment. 3. Fever, defined as an oral temperature> 38 ° C, axillary> 38.1 ° C, 4. Chest x-ray (forehead and profile), within 48 hours prior to the administration of the first IV dose of the study drug, evidencing the presence of an infiltrate.
Exclusion criteria
Exclusion criteria: 1. Any disease concomitant condition that, in the opinion of the investigator, could interfere in the evaluation of a response or hinder the course of the therapy so that it can not be completed. 2. Hospitalization within 14 days prior to the onset of symptoms. 3. Residence in a chronic disease care institution. 4. Score V in the Fine Scale for the determination of the severity index of pneumonia or order indication of hospitalization in the intensive care unit. 5. Hemodialysis, periloneal dialysis, plasmapheresis or concurrent hemoperfusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be recorded from the moment a subject signs the informed consent form. Laboratory tests (hematology, blood chemistry, and coagulation), chest x-rays, and electrocardiograms (ECG) will be evaluated. Measure:Comparison of the safety of tigecycline with the safety of levofloxacin in subjects with CAP who require hospitalization Timepoints:3 days after the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical response: cure, failure or indeterminate. Measure:The clinical and microbiological efficacy of tigecycline and levofloxacin will be evaluated Timepoints:10 to 21 days post treatment | — |
Countries
Argentina, Brazil, Chile, Costa Rica, Guatemala, Mexico, Peru, United States, Venezuela
Outcome results
None listed