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

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ClinicalTrials.gov Identifier: NCT00079976
Recruitment Status : Completed
First Posted : March 22, 2004
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Gram-Positive Bacterial Infections Staphylococcus Infections Vancomycin Resistance Methicillin Resistance Drug: Tigecycline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : October 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA
U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079976


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00079976     History of Changes
Other Study ID Numbers: 3074A1-307
First Posted: March 22, 2004    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Staphylococcus aureus
Bacterial Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Vancomycin
Methicillin
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents