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

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)

NCT00079976•Wyeth is now a wholly owned subsidiary of Pfizer

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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

Age

18 - No limit years

Sex

ALL

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)

Key Dates

Start Date

October 1, 2003

Primary Completion Date

June 1, 2005

Completion Date

June 1, 2005

Last Updated

February 8, 2013

Enrollment

174

ACTUAL participants

Conditions

Gram-Positive Bacterial InfectionsStaphylococcus InfectionsVancomycin ResistanceMethicillin Resistance

Interventions

Tigecycline

DRUG

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

NCT05824988

Mycobacterium Avium ComplexMycobacterium Avium-Intracellulare Infection+2 more

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NOT_YET_RECRUITINGPHASE2/PHASE3

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

NCT07221708

Clostridioides DifficileVancomycin Resistance Enterococcus Faecium

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

Clinical Decision Support Tool for Vancomycin Dosing in Children

TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings