Endophthalmitis Cultures (PROSPER)

February 20, 2017 updated by: Stephen J. Kim, MD, Vanderbilt University

Prospective Surveillance of Patients With Endophthalmitis for Multi-antibiotic Resistance (PROSPER) Study

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Vanderbilt Eye Institute

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endophthalmitis cultures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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