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Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

Last updated on May 11, 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.
Gram-Negative Bacterial Infections
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 or female subjects aged 18 years or older

- Isolation of a resistant gram-negative pathogen, eg, Enterobacter species,
Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative
pathogens, alone or as 1 isolate of a polymicrobial infection

- Resistant gram-negative organisms are defined by the likely presence of ESBL or
related mechanisms which limit the therapeutic alternatives for the treatment of
complicated infections

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

- Subjects with any concomitant condition or taking any concomitant medication that, in
the opinion of the investigator, could preclude an evaluation of a response or make it
unlikely that the contemplated course of therapy or follow-up assessment will be
completed or that will substantially increase the risk associated with the subject's
participation in this study

- Anticipated length of antibiotic therapy

- Known or suspected hypersensitivity to tigecycline or other compounds related to this
class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

NCT00079989
Pfizer
Completed
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

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Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
A Phase 3, Open-label, Noncomparative Study of Tigecycline for the Treatment of Subjects With Selected Serious Infections Due to Resistant Gram-negative Organisms Such as Enterobacter Species, Acinetobacter Baumannii, and Klebsiella Pneumoniae
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.
Not Provided
Interventional
Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Gram-Negative Bacterial Infections
Drug: tigecycline
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
November 2005
November 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged 18 years or older
  • Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
  • Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections

Exclusion Criteria:

  • Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
  • Anticipated length of antibiotic therapy < 7 days
  • Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)
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
 
NCT00079989
3074A1-309
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.

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