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

Bacterial Pneumonia Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081575
• Other study ID #: 3074A1-313
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2004
• Last updated: February 7, 2013
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Community-Acquired Infections
• Cross Infection
• Infection
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Tigecycline

• Levofloxacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Primary	Determine whether tigecycline is noninferior to levofloxacin.