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

Last updated: February 7, 2013
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

3

Condition

Staphylococcal Infections

Bacterial Infections

Treatment

N/A

Clinical Study ID

NCT00079976
3074A1-307
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 polymicrobialinfection

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

Exclusion

Exclusion Criteria:

  • Subjects with any concomitant condition or taking any concomitant medication that, inthe opinion of the investigator, could preclude an evaluation of a response or make itunlikely that the contemplated course of therapy or follow-up assessment will becompleted or that will substantially increase the risk associated with the subject'sparticipation in this study

  • Anticipated length of antibiotic therapy less than 7 days

  • For subjects with VRE, known or suspected hypersensitivity to tigecycline orlinezolid, 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 compoundsrelated to these classes of antibacterial agents (eg, tetracyclines, minocycline,doxycycline)

Study Design

Total Participants: 174
Study Start date:
October 01, 2003
Estimated Completion Date:
June 30, 2005