You are here

Our science / Clinical Trials / Find a Trial / NCT00079885

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

Back to Search Print Save as PDF Bookmark Trial

NCT00079885

Last updated on May 12, 2018
Back to Search Print Save as PDF Bookmark Trial

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 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Pneumococcal Infections
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
NCT03571607
All Genders
6+
Years
Multiple Sites
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
NCT03642847
All Genders
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
NCT03512288
All Genders
0+
Years
Multiple Sites
Group B Streptococcal Infections
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
NCT03170609
All Genders
18+
Years
Multiple Sites
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now