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

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ClinicalTrials.gov Identifier: NCT00081575
Recruitment Status : Completed
First Posted : April 19, 2004
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Community-Acquired Infections Bacterial Pneumonia Cross Infection Drug: Tigecycline Drug: Levofloxacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Masking: Double
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
Study Start Date : January 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
  2. Determine whether tigecycline is noninferior to levofloxacin.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081575


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00081575     History of Changes
Other Study ID Numbers: 3074A1-313
First Posted: April 19, 2004    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Bacterial Pneumonia
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Pneumonia, Bacterial
Community-Acquired Infections
Cross Infection
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Levofloxacin
Ofloxacin
Tigecycline
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors