EndophthalmitisNCT01323868
Endogenous Endophthalmitis in the Inpatient Setting
An observational study of Endophthalmitis, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients at Stanford Hospital with positive blood cultures who receive an Ophthalmology consultation and eye examination.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Endogenous Endophthalmitis Rates, Clinical Course, and Outcomes
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.
Read the 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.
- Conditions
- Endophthalmitis
- Medical subject headings
- Endophthalmitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive intraocular infection
Measured: 1 day
Secondary outcomes (1)
Visual acuity
Measured: 2 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Leng, Stanford University
- Investigators
- Theodore Leng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323868
- Sponsor's protocol ID
- SU-03232011-7621
- Other IDs
- IRB-18785
- Status last verified
- Nov 2014
- First submitted
- 24 Mar 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Endophthalmitis Rates, Clinical Course, and Outcomes
- ClinicalTrials.gov ID
- NCT01323868
- Acronym / sponsor ID
- SU-03232011-7621
- Conditions
- Endophthalmitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients at Stanford Hospital with positive blood cultures who receive an Ophthalmology consultation and eye examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive intraocular infection
Time frame: 1 day
1 secondary outcome
Visual acuity
Time frame: 2 wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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Endophthalmitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Leng principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endophthalmitis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive intraocular infection (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.