InfectionNCT01746888
Expanding Antimicrobial Stewardship
An observational study of Infection, run by Jeffrey Caterino at 1 site in United States.
Trial summary
Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- How many people
- 437 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults 65 years of age and older who present to the Emergency Department.
Who may be able to join
- 65 years of age
Who cannot join
- Patient incarcerated
- Chief complaint of suicidal or homicidal ideation
- Patient primarily evaluated by the trauma team
Trial locations and contacts
1 site in 1 country.
United States1 site
Wexner Medical Center at The Ohio State University
Columbus, Ohio, 43210
About this study
Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.
- Conditions
- Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults | Adults 65 years and older who present to the Emergency Department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of infection while in the Emergency Department
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Caterino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Caterino, Ohio State University
- Investigators
- Jeffrey M Caterino, MD, MPH, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746888
- Sponsor's protocol ID
- 2011H0165
- Status last verified
- Nov 2013
- First submitted
- 23 Oct 2012
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Antimicrobial Stewardship
- ClinicalTrials.gov ID
- NCT01746888
- Acronym / sponsor ID
- 2011H0165
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Jeffrey CaterinoUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Dec 2012 (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.
Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults | – | –Adults 65 years and older who present to the Emergency Department. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults 65 years of age and older who present to the Emergency Department.
Key inclusion criteria (1 listed)
- 65 years of age
Key exclusion criteria (3 listed)
- Patient incarcerated
- Chief complaint of suicidal or homicidal ideation
- Patient primarily evaluated by the trauma team
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
Presence of infection while in the Emergency Department
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days.
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 8 Nov 2013.
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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.
Jeffrey M Caterino, MD, MPH principal investigator
Ohio State 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 Infection, run by Jeffrey Caterino at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. 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?
Presence of infection while in the Emergency Department (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days.). 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 8 Nov 2013.