Back to resultsStudy Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Primary Purpose
Community-Acquired Infections, Bacterial Pneumonia, Cross Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tigecycline
Levofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Community-Acquired Infections focused on measuring Bacterial Pneumonia
Eligibility 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.
Sites / Locations
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00081575
First Posted
April 15, 2004
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00081575
Brief Title
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Infections, Bacterial Pneumonia, Cross Infection
Keywords
Bacterial Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
434 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Primary Outcome Measure Information:
Title
Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Title
Determine whether tigecycline is noninferior to levofloxacin.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22812672
Citation
Ramirez JA, Cooper AC, Wiemken T, Gardiner D, Babinchak T; 308 Study Group. Switch therapy in hospitalized patients with community-acquired pneumonia: tigecycline vs. levofloxacin. BMC Infect Dis. 2012 Jul 19;12:159. doi: 10.1186/1471-2334-12-159.
Results Reference
derived
PubMed Identifier
19740418
Citation
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. doi: 10.1186/1471-2466-9-44.
Results Reference
derived
PubMed Identifier
19036672
Citation
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. doi: 10.1179/joc.2008.20.Supplement-1.28.
Results Reference
derived
PubMed Identifier
18508226
Citation
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. doi: 10.1016/j.diagmicrobio.2008.04.009. Epub 2008 May 27.
Results Reference
derived
Learn more about this trial
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
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