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

This study has been completed.

First Received on April 15, 2004. Last Updated on October 9, 2007 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00081575

Purpose

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

Condition	Intervention	Phase
Community-Acquired Infections Bacterial Pneumonia Cross Infection	Drug: Tigecycline Drug: Levofloxacin	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride Tigecycline

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

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.

Study Start Date:

September 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081575

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tanaseanu C, Milutinovic S, Calistru PI, Strausz J, Zolubas M, Chernyak V, Dartois N, Castaing N, Gandjini H, Cooper CA; 313 Study Group. Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia. BMC Pulm Med. 2009 Sep 9;9:44.

Dartois N, Castaing N, Gandjini H, Cooper A; Tigecycline 313 Study Group. Tigecycline versus levofloxacin for the treatment of community-acquired pneumonia: European experience. J Chemother. 2008 Oct;20 Suppl 1:28-35.

Tanaseanu C, Bergallo C, Teglia O, Jasovich A, Oliva ME, Dukart G, Dartois N, Cooper CA, Gandjini H, Mallick R; 308 Study Group; 313 Study Group. Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jul;61(3):329-38. Epub 2008 May 27.

ClinicalTrials.gov Identifier:	NCT00081575 History of Changes
Other Study ID Numbers:	3074A1-313
Study First Received:	April 15, 2004
Last Updated:	October 9, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Bacterial Pneumonia

Additional relevant MeSH terms:

Pneumonia, Bacterial
Cross Infection
Pneumonia
Community-Acquired Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Ofloxacin

Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 12, 2012