Endophthalmitis Cultures | NCT01496794

Studies
Endophthalmitis Cultures

NCT01496794

Sponsor

Vanderbilt University

Status

Terminated

Last Update Posted

Feb 23, 2017Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Endophthalmitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor enrollment

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Dec 19, 2011

First Submission Date that Met QC Criteria

Dec 19, 2011

First Posted Date

Dec 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2017

Last Update Posted Date

Feb 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen J. Kim, MD, Assistant Professor of Ophthalmology, Vanderbilt UniversityPrincipal Investigator

Lead Sponsor

Vanderbilt UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Label	Type	Description	Intervention Names
Endophthalmitis cultures

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Vanderbilt Eye Institute

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen J Kim, MD	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Eye Institute		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D009877	Endophthalmitis

Ancestor Terms

ID	Term
D015817	Eye Infections
D007239	Infections
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided