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Clinical Outcomes and Global Epidemiology -Data Coordinating Center

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00524563
Collaborator
(none)
400
Enrollment
1
Location
119
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include the following: To determine the impact of inactive empiric antimicrobial therapy, defined as receipt of empiric antimicrobial therapy with no in vitro activity against the offending isolate for at least 24hrs, on the outcome (end points defined below) of patients with Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or tigecycline if these agents were tested) on the outcome of patients with Acinetobacter bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome of patients with Acinetobacter bloodstream infection. To characterize the molecular epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are clonally related and to characterize the mechanisms of resistance in Acinetobacter on a global scale.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Medical records will be reviewed and information collected from charts to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. 24 sites will participate and all information will be loaded into a password protected database.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Outcomes and Global Epidemiology -Data Coordinating Center
    Actual Study Start Date :
    Jul 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Acinetobacter bloodstream infection
      Exclusion Criteria:
      • Does not meet entry criteria

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213

      Sponsors and Collaborators

      • University of Pittsburgh

      Investigators

      • Principal Investigator: David Paterson, MD, University of Pittsburgh Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Pittsburgh
      ClinicalTrials.gov Identifier:
      NCT00524563
      Other Study ID Numbers:
      • PRO07080042
      First Posted:
      Sep 3, 2007
      Last Update Posted:
      Jun 12, 2018
      Last Verified:
      Jun 1, 2018
      Keywords provided by University of Pittsburgh
      Acinetobacter
      bloodstream infection
      Isolate
      Additional relevant MeSH terms:
      Acinetobacter Infections

      Study Results

      No Results Posted as of Jun 12, 2018