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Endophthalmitis Cultures (PROSPER)

This study has been terminated.
(poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496794
First Posted: December 21, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen J. Kim, MD, Vanderbilt University
  Purpose

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
Endophthalmitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Surveillance of Patients With Endophthalmitis for Multi-antibiotic Resistance (PROSPER) Study

Further study details as provided by Stephen J. Kim, MD, Vanderbilt University:

Enrollment: 3
Study Start Date: October 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endophthalmitis cultures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Vanderbilt Eye Institute
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496794


Locations
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen J Kim, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Stephen J. Kim, MD, Assistant Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01496794     History of Changes
Other Study ID Numbers: 100487
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endophthalmitis
Eye Infections
Infection
Eye Diseases