None listed
Conditions
Interventions
Intravenous tigecycline is administered for a minimum of 3 days and a maximum of 14 days.
Group name:levofloxacin Type of group
Intravenous levofloxacin is administered for a minimum of 3 days and a maximum of 14 days.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of male or female sex> 18 years of age. 2. Subjects hospitalized with NAC for whom a treatment is indicated with IV antibiotics. 3. The presence of fever (within 24 hours prior to randomization) defined as an oral temperature> 38 ° C / 100.4 ° F, axillary temperature. 5. X-ray of the chest (if possible, posteroanterior and lateral) within the 48 hours prior to the first dose of test article IV showing the presence of a new infiltrate.
Exclusion criteria
Exclusion criteria: 1. Any concomitant condition 2. Hospitalization within 14 days prior to the appearance of the symptom. 3. Residence in a long-term care center or private clinic> 14 days before the onset of symptoms. 4. Score on the Fine Severity index of V or a required treatment in an intensive care unit. 5. Hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis concurrent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The vital signs will be monitored daily while drug IV is being administered. The evaluation of the clinical signs and symptoms of NAC will be made and they will be recorded daily during the administration. Adverse events (AE) will be recorded from the moment in which a subject signs the informed consent form. Measure:evaluation of the safety of the drug Timepoints:21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical and microbiological efficacy will be evaluated Measure:Evaluation of the effectiveness of the drug Timepoints:21 days | — |
Countries
Peru
Outcome results
None listed