Bacterial Pneumonia, Community-Acquired Infections, Cross Infection
Conditions
Keywords
Bacterial Pneumonia
Brief summary
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Interventions
DRUGTigecycline
DRUGLevofloxacin
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit. | — |
| Determine whether tigecycline is noninferior to levofloxacin. | — |
Outcome results
None listed