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OpenTrials
Active, Not Recruiting

NCT Number: NCT01879761

Immune Resolution After Staphylococcus Aureus Bacteremia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Immune Response To Sepsis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infections Staphylococcus Aureus Infection Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. New Infections

    Time frame: 0-90 days

Other outcomes

  1. Mortality

    Time frame: 0-90 days

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2013
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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