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

Last updated on May 12, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Pneumonia, Bacterial Pneumonia, Cross Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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

NCT00079885
Pfizer
Completed
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

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Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Community Acquired Pneumonia
  • Bacterial Pneumonia
  • Cross Infection
Drug: tigecycline
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
July 2005
July 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00079885
3074A1-308
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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