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Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Last updated on December 15, 2017

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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-Positive Bacterial Infections, Staphylococcus Infections, Vancomycin Resistance, Methicillin Resistance
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 one of the following multi-antibiotic resistant bacteria:
vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis,
or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial
infection

- Have a confirmed diagnosis of a serious infection (eg, bacteremia [unless due to an
excluded infection], complicated intra-abdominal infection, complicated skin and skin
structure infection, or pneumonia) requiring administration of intravenous (IV)
antibiotic therapy

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 less than 7 days

- For subjects with VRE, known or suspected hypersensitivity to tigecycline or
linezolid, or other compounds related to these classes of antibacterial agents (eg,
oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA,
known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds
related to these classes of antibacterial agents (eg, tetracyclines, minocycline,
doxycycline)

NCT00079976
Pfizer
Completed
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

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Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
A Clinical Research Study to Evaluate the Safety and Efficacy of Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Gram-Positive Bacterial Infections
  • Staphylococcus Infections
  • Vancomycin Resistance
  • Methicillin Resistance
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
174
June 2005
June 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged 18 years or older
  • Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection
  • Have a confirmed diagnosis of a serious infection (eg, bacteremia [unless due to an excluded infection], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy

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 less than 7 days
  • For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes 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
 
NCT00079976
3074A1-307
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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