Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
Information source: Wyeth
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Acquired Pneumonia; Bacterial Pneumonia; Cross Infection
Intervention: tigecycline (Drug)
Phase: Phase 3
Sponsored by: Wyeth
Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth Research
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.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Study design: Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Minimum age: 18 Years.
Maximum age: N/A.
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
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Last updated: October 9, 2007