NCT00037050

Brief Summary

This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
739

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2002

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

First QC Date

May 14, 2002

Last Update Submit

September 11, 2009

Conditions

Bacterial InfectionsGram-Positive Bacterial InfectionsBacteremia

Outcome Measures

Primary Outcomes (2)

  • The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;

  • The empiric treatment of patients with gram-positive catheter-related bloodstream infections.

Secondary Outcomes (1)

  • Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid

Interventions

LinezolidDRUG
Also known as: Zyvox
VancomycinDRUG
OxacillinDRUG
DicloxacillinDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a central indwelling catheter with signs and symptoms of infection

You may not qualify if:

  • Patients with tunneled catheter which cannot be removed.
  • Patients with evidence of endovascular infection including endocarditis.
  • Patients with infection of permanent intravascular devices.
  • Patients who have received more than 1 day of another antibiotic before enrollment.
  • Patients with HIV and low CD4 count.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bacterial InfectionsGram-Positive Bacterial InfectionsBacteremia

Interventions

LinezolidVancomycinOxacillinDicloxacillin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsPenicillinsbeta-LactamsLactamsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCloxacillin

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 14, 2002

First Posted

May 15, 2002

Study Start

April 1, 2002

Study Completion

July 1, 2005

Last Updated

September 14, 2009

Record last verified: 2009-09