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Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
This study has been completed.
First Received: April 15, 2004   Last Updated: October 9, 2007   History of Changes
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

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

Resource links provided by NLM:


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

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 3074A1-313
Study First Received: April 15, 2004
Last Updated: October 9, 2007
ClinicalTrials.gov Identifier: NCT00081575     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
Community-Acquired Infections
Anti-Infective Agents, Urinary
Pneumonia
Cross Infection

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
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
Therapeutic Uses
Pneumonia, Bacterial
Lung Diseases
Community-Acquired Infections
Nucleic Acid Synthesis Inhibitors
Cross Infection
Pneumonia

ClinicalTrials.gov processed this record on July 02, 2009