InfectionEMOSNCT01746407
Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis
An observational study of Infection, run by Abbott Diagnostics Division at 2 sites in United States.
Trial summary
Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 872 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Presentation to an emergency department
Who may be able to join
- 18 yrs of age or older
- For women of child bearing years: not known to be pregnant
- Blood culture ordered as part of the ED, ICU (or equivalent) or hospital floor stay.
Who cannot join
- Previously enrolled in this study
- Vulnerable individual
- Unable to speak and/or understand English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital
Atlanta, Georgia, 30303
Grady Memorial Hospital
Atlanta, Georgia, 30303
About this study
Official title: Observational Study to Procure Human Specimens for Use in the Diagnosis and Management of Sepsis and Other Related Conditions
Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc.
- Conditions
- Infection
- Keywords
- Emergency Department, Infection, Sepsis
- Medical subject headings
- Infections, Emergencies, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of infection to severe sepsis
Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection.
Measured: 72 hours
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 startDec 2012
- Primary completionAug 2014
- Study completionDec 2014
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
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diagnostics Division
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg S Martin, MD, M.Sc., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746407
- Sponsor's protocol ID
- 09DELK12
- Acronym
- EMOS
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2012
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Procure Human Specimens for Use in the Diagnosis and Management of Sepsis and Other Related Conditions
- ClinicalTrials.gov ID
- NCT01746407
- Acronym / sponsor ID
- EMOS / 09DELK12
- Conditions
- Infection
- Keywords
- Emergency Department, Infection, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Abbott Diagnostics DivisionIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (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.
Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Presentation to an emergency department
Key inclusion criteria (3 listed)
- 18 yrs of age or older
- For women of child bearing years: not known to be pregnant
- Blood culture ordered as part of the ED, ICU (or equivalent) or hospital floor stay.
Key exclusion criteria (3 listed)
- Previously enrolled in this study
- Vulnerable individual
- Unable to speak and/or understand English
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
Progression of infection to severe sepsis
Time frame: 72 hours
Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection.
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 30 Dec 2015.
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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.
Greg S Martin, MD, M.Sc. principal investigator
Emory University
2 sites 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 Abbott Diagnostics Division at 2 sites 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 3 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 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Progression of infection to severe sepsis (time frame: 72 hours). 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 30 Dec 2015.