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

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NCT00081575

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Infections, Bacterial Pneumonia, Cross Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 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 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
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 before the onset of symptoms.

- Residence in a long-term care facility or nursing home ?14 days before the onset of
symptoms.

NCT00081575
Pfizer
Completed
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

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Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
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
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Community-Acquired Infections
  • Bacterial Pneumonia
  • Cross Infection
  • Drug: Tigecycline
  • Drug: Levofloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
434
March 2005
March 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Bulgaria,   Croatia,   Czech Republic,   Estonia,   Germany,   Hungary,   India,   Latvia,   Lithuania,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Ukraine
 
NCT00081575
3074A1-313
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

FOR MORE INFORMATION

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1-800-718-1021

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