Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
Completed
Wyeth is now a wholly owned subsidiary of Pfizer
Phase 3
2003-11-01
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.
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Completed
Wyeth is now a wholly owned subsidiary of Pfizer
Phase 3
2003-10-01
To evaluate the safety and efficacy of tigecycline in the treatment of selected serious
infections caused by VRE. The primary efficacy endpoint will be the clinical response for all
subjects.
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
Completed
Wyeth is now a wholly owned subsidiary of Pfizer
Phase 3
2003-12-01
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected
serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii,
Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for
whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial
therapies. The primary efficacy endpoint will be the clinical response.
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