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

This study has been completed.

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00079976
  Purpose

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.


Condition Intervention Phase
Gram-Positive Bacterial Infections
Staphylococcus Infections
Vancomycin Resistance
Methicillin Resistance
Drug: Tigecycline
Phase III

MedlinePlus related topics:   Bacterial Infections    Staphylococcal Infections   

ChemIDplus related topics:   Tigecycline    Vancomycin    Vancomycin hydrochloride    Methicillin    Methicillin sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Official Title:   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)
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079976

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor, MD     Wyeth    
  More Information

Study ID Numbers:   3074A1-307
First Received:   March 19, 2004
Last Updated:   October 9, 2007
ClinicalTrials.gov Identifier:   NCT00079976
Health Authority:   United States: Food and Drug Administration

Keywords provided by Wyeth:
Staphylococcus aureus  
Bacterial Infections  

Study placed in the following topic categories:
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin
Tigecycline
Vancomycin

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




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