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

Sponsored by:	Wyeth
Information provided by:	Wyeth
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

MedlinePlus related topics: Pneumonia

Drug Information available for: Tigecycline Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

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

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Publications indexed to this study:

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.

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

Keywords provided by Wyeth:

Bacterial Pneumonia

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Tigecycline
Lung Diseases

Pneumonia, Bacterial
Ofloxacin
Community-Acquired Infections
Pneumonia
Cross Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Renal Agents
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009