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Endogenous Endophthalmitis in the Inpatient Setting

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.
 
ClinicalTrials.gov Identifier: NCT01323868
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Theodore Leng, Stanford University

Tracking Information
First Submitted Date March 24, 2011
First Posted Date March 28, 2011
Last Update Posted Date November 18, 2014
Study Start Date July 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2011)
Positive intraocular infection [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 24, 2011)
Visual acuity [ Time Frame: 2 wk ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endogenous Endophthalmitis in the Inpatient Setting
Official Title Endogenous Endophthalmitis Rates, Clinical Course, and Outcomes
Brief Summary The purpose of this study is to determine the rate of endogenous endophthalmitis in patients admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this may improve the clinical care of this population of patients.
Detailed Description

Some patients admitted to the hospital have blood-borne infections. Occasionally, these blood infections can end up inside the eye and cause an infection inside the eye (called endogenous endophthalmitis).

Prior to modern and rapid treatment of systemic infections, the rate of endogenous endophthalmitis was reported to be 37% in 1982. By 1997, the rate was reported to be 2.8%. This study aims to determine the rate of endogenous endophthalmitis at Stanford Hospital in the modern medical era in that our rates may be different as those reported in the literature. This potential difference may be a reflection of treatment protocols and antibiotics currently in use at Stanford Hospital.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients at Stanford Hospital with positive blood cultures who receive an Ophthalmology consultation and eye examination.
Condition Endophthalmitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 17, 2014)
145
Original Estimated Enrollment
 (submitted: March 24, 2011)
390
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria Inclusion Criteria:All patients admitted to Stanford Hospital that have a systemic blood-borne infection and on which an Ophthalmology consult to rule out endogenous endophthalmitis is performed will be included in the study. Exclusion Criteria:None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01323868
Other Study ID Numbers SU-03232011-7621
IRB-18785
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Theodore Leng, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Theodore Leng Stanford University
PRS Account Stanford University
Verification Date November 2014