Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.
Condition or disease
Community Acquired PneumoniaBacterial PneumoniaCross Infection
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female subjects ≥ 18 years of ag.
Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature >38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95°
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 prior to the onset of symptoms
Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms