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Trial record 1 of 1 for:    NCT00081575
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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

Tracking Information
First Submitted Date  ICMJE April 15, 2004
First Posted Date  ICMJE April 19, 2004
Last Update Posted Date February 8, 2013
Study Start Date  ICMJE January 2004
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00081575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Official Title  ICMJE 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
Brief Summary To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Community-Acquired Infections
  • Bacterial Pneumonia
  • Cross Infection
Intervention  ICMJE
  • Drug: Tigecycline
  • Drug: Levofloxacin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2013)
434
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Bulgaria,   Croatia,   Czech Republic,   Estonia,   Germany,   Hungary,   India,   Latvia,   Lithuania,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT00081575
Other Study ID Numbers  ICMJE 3074A1-313
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP