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PROSPER: Endophthalmitis Cultures

Sponsor
Vanderbilt University (Other)
Overall Status
Terminated
CT.gov ID
NCT01496794
Collaborator
(none)
3
Enrollment
1
Location
54
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The intent of this surveillance study will be to obtain written permission from patients with bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with vancomycin, ceftazidime, and moxifloxacin.

Research hypothesis:

  1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to "standard therapy" with vancomycin and ceftazidime.

  2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing rates of multi-antibiotic resistance.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Adult patients over 18 years of age presenting with endophthalmitis and able to sign consent.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Surveillance of Patients With Endophthalmitis for Multi-antibiotic Resistance (PROSPER) Study
    Study Start Date :
    Oct 1, 2011
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Apr 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Endophthalmitis cultures

    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:
      • all adult patients age 18 or greater presenting with bacterial endophthalmitis to the Vanderbilt Eye Institute and who grow positive cultures
      Exclusion Criteria:
      • Patients < 18 years of age or those patients without positive cultures

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Vanderbilt Eye Institute Nashville Tennessee United States 37232

      Sponsors and Collaborators

      • Vanderbilt University

      Investigators

      • Principal Investigator: Stephen J Kim, MD, Vanderbilt University Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Stephen J. Kim, MD, Assistant Professor of Ophthalmology, Vanderbilt University
      ClinicalTrials.gov Identifier:
      NCT01496794
      Other Study ID Numbers:
      • 100487
      First Posted:
      Dec 21, 2011
      Last Update Posted:
      Feb 23, 2017
      Last Verified:
      Feb 1, 2017
      Additional relevant MeSH terms:
      Endophthalmitis

      Study Results

      No Results Posted as of Feb 23, 2017