NCT01496794

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.5 years

First QC Date

December 19, 2011

Last Update Submit

February 20, 2017

Conditions

Endophthalmitis

Study Arms (1)

Endophthalmitis cultures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vanderbilt Eye Institute

You may qualify if:

  • all adult patients age 18 or greater presenting with bacterial endophthalmitis to the Vanderbilt Eye Institute and who grow positive cultures

You may not qualify if:

  • Patients \< 18 years of age or those patients without positive cultures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Study Officials

  • Stephen J Kim, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)