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

This study has been completed.

First Received: March 19, 2004 Last Updated: October 9, 2007 History of Changes

Sponsor:	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

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)

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Staphylococcal Infections

Drug Information available for: Methicillin Tigecycline Methicillin sodium Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Wyeth:

Staphylococcus aureus
Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Staphylococcal Infections
Communicable Diseases
Gram-Positive Bacterial Infections

Methicillin
Tigecycline
Therapeutic Uses
Vancomycin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009