Immune Resolution After Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Infection Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01879761
• Other study ID #: 13-0491
• Status: Active, not recruiting
• Start date: June 2013
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Response To Sepsis
• Staphylococcal Infections
• Staphylococcus Aureus Infection

Locations

Country	Name	City	State
United States	University of Chicago Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		0-90 days
Primary	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	New Infections		0-90 days