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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00079976

Collaborator

(none)

174

Enrollment

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Oct 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)