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

Tracking Information

First Received Date ^ICMJE

April 15, 2004

Last Updated Date

October 9, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00081575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Condition ^ICMJE

Community-Acquired Infections
Bacterial Pneumonia
Cross Infection

Intervention ^ICMJE

Drug: Tigecycline
Drug: Levofloxacin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00081575

Responsible Party

Study ID Numbers ^ICMJE

3074A1-313

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP