Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00079885

Purpose

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.

Condition	Intervention	Phase
Community Acquired Pneumonia Bacterial Pneumonia Cross Infection	Drug: tigecycline	Phase III

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 Tigecycline Vs 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects ≥ 18 years of ag.
Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
The presence of fever (within 24 hours prior to randomization), defined as oral temperature >38°C/100.4°F, axillary temperature >38.1°C/100.6°F, tympanic temperature >38.5°C/ 101.2°F, or a rectal/core temperature >39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature <35°C/95°

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 prior to 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: NCT00079885

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bergallo C, Jasovich A, Teglia O, Oliva ME, Lentnek A, de Wouters L, Zlocowski JC, Dukart G, Cooper A, Mallick R; 308 Study Group. Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. Diagn Microbiol Infect Dis. 2009 Jan;63(1):52-61. Epub 2008 Nov 5.

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:	3074A1-308
Study First Received:	March 18, 2004
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00079885 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Bacterial Pneumonia

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Tigecycline
Lung Diseases

Pneumonia, Bacterial
Ofloxacin
Anti-Infective Agents, Urinary
Pneumonia
Cross Infection

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Tigecycline
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Infection
Pharmacologic Actions

Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumonia, Bacterial
Lung Diseases
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Cross Infection
Pneumonia

ClinicalTrials.gov processed this record on July 02, 2009