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Immune Resolution After Staphylococcus Aureus Bacteremia

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The University of Chicago

Status

Active, not recruiting

Conditions

Staphylococcus Aureus Infection
Immune Response To Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT01879761
13-0491

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Immunosuppressed
Description:
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
Description:
Subject does not fit immunosuppressed criteria

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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