Immune Resolution After Staphylococcus Aureus Bacteremia

August 13, 2025 updated by: University of Chicago

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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital inpatients with Staphylococcus aureus bacteremia who are over 18 years old.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Sequential Organ Failure Assessment (SOFA) score > 12 on day of positive blood cultures
  • Survival expected to be < 7 days from positive blood cultures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
New Infections
Time Frame: 0-90 days
0-90 days

Other Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 0-90 days
0-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimated)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0491

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Staphylococcus Aureus Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe