Immune Resolution After Staphylococcus Aureus Bacteremia

NCT01879761 | Active Not Recruiting

• 1 other identifier: 13-0491
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Immune Response To Sepsis; Staphylococcus Aureus Infection

Keywords

Immunosuppressed; Sepsis; Staphylococcus Aureus; Bacteremia; HLA-DR

Outcome Measures

Primary Outcomes (1)

• HLA-DR and cytokines

  Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA.

  0-30 days

Secondary Outcomes (1)

• New Infections

  0-90 days

Other Outcomes (1)

• Mortality

  0-90 days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Isolated monocytes from whole blood for HLA-DR measurement. Serum and plasma for cytokine measurements

MeSH Terms

Conditions

Staphylococcal Infections; Sepsis; Bacteremia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)