Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Wyeth

Status and phase: Completed; Phase 3

Conditions: Cross Infection; Bacterial Pneumonia; Community-Acquired Infections

Treatments: Drug: Levofloxacin; Drug: Tigecycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00081575

3074A1-313

Details and patient eligibility

About

To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.

Enrollment: 434 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
• Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
• The presence of fever (within 24 hours before randomization)

Exclusion criteria

• Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy <30 days).
• Hospitalization within 14 days before the onset of symptoms.
• Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms.