Immune Response To SepsisNCT01879761
Immune Resolution After Staphylococcus Aureus Bacteremia
An observational study of Immune Response To Sepsis and Staphylococcus Aureus Infection, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Response To Sepsis, Staphylococcus Aureus Infection
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hospital inpatients with Staphylococcus aureus bacteremia who are over 18 years old.
Who may be able to join
- At least one blood culture positive for S. aureus
- Patients aged ≥18 years
- At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:
- Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F)
- Heart rate greater than 90 beats per minute
- Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg
- WBC less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L); or the presence of greater than 10% immature neutrophils (band forms)
Who cannot join
- Sequential Organ Failure Assessment (SOFA) score > 12 on day of positive blood cultures
- Survival expected to be < 7 days from positive blood cultures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospital
Chicago, Illinois, 60637
About this study
The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia.
We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.
- Keywords
- Immunosuppressed, Sepsis, Staphylococcus Aureus, Bacteremia, HLA-DR
- Medical subject headings
- Staphylococcal Infections, Sepsis, Bacteremia
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 |
|---|---|---|
| Immunosuppressed | Immunosuppressed includes patients with any one of the following: 1. a diagnosis of a hematological malignancy 2. a diagnosis of HIV 3. myelosuppressive chemotherapy in the previous 90 days 4. immune-modulating medications in the previous 90 days | |
| Non-Immunosuppressed | Subject does not fit immunosuppressed criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
HLA-DR and cytokines
Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA.
Measured: 0-30 days
Secondary outcomes (1)
New Infections
Measured: 0-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Response To SepsisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879761
- Sponsor's protocol ID
- 13-0491
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2013
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Resolution After Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT01879761
- Acronym / sponsor ID
- 13-0491
- Keywords
- Immunosuppressed, Sepsis, Staphylococcus Aureus, Bacteremia, HLA-DR
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jun 2013 (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 how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia.
We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppressed | – | –Immunosuppressed includes patients with any one of the following: 1. a diagnosis of a hematological malignancy 2. a diagnosis of HIV 3. myelosuppressive chemotherapy in the previous 90 days 4. immune-modulating medications in the previous 90 days |
| Non-Immunosuppressed | – | –Subject does not fit immunosuppressed criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital inpatients with Staphylococcus aureus bacteremia who are over 18 years old.
Key inclusion criteria (7 listed)
- At least one blood culture positive for S. aureus
- Patients aged ≥18 years
- At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:
Key exclusion criteria (2 listed)
- Sequential Organ Failure Assessment (SOFA) score > 12 on day of positive blood cultures
- Survival expected to be < 7 days from positive blood cultures
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
HLA-DR and cytokines
Time frame: 0-30 days
Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA.
1 secondary outcome
New Infections
Time frame: 0-90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immune Response To Sepsis and Staphylococcus Aureus Infection, run by University of Chicago 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
HLA-DR and cytokines (time frame: 0-30 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 13 Jul 2026.