Immune Resolution After Staphylococcus Aureus Bacteremia

NCT ID: NCT01879761

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Immune Response To Sepsis Staphylococcus Aureus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Non-Immunosuppressed

Subject does not fit immunosuppressed criteria

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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13-0491

Identifier Type: -

Identifier Source: org_study_id

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