Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT01879761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Resolution After Staphylococcus Aureus Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Isolated monocytes from whole blood for HLA-DR measurement. Serum and plasma for cytokine measurements'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '0-90 days'}], 'primaryOutcomes': [{'measure': 'HLA-DR and cytokines', 'timeFrame': '0-30 days', 'description': 'Percent expression of HLA-DR on monocytes will be measured by flow cytometry. Cytokine levels will be measured by ELISA.'}], 'secondaryOutcomes': [{'measure': 'New Infections', 'timeFrame': '0-90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunosuppressed', 'Sepsis', 'Staphylococcus Aureus', 'Bacteremia', 'HLA-DR'], 'conditions': ['Immune Response To Sepsis', 'Staphylococcus Aureus Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital inpatients with Staphylococcus aureus bacteremia who are over 18 years old.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one blood culture positive for S. aureus\n* Patients aged ≥18 years\n* At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:\n\n * Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F)\n * Heart rate greater than 90 beats per minute\n * Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg\n * 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)\n\nExclusion Criteria:\n\n* Sequential Organ Failure Assessment (SOFA) score \\> 12 on day of positive blood cultures\n* Survival expected to be \\< 7 days from positive blood cultures'}, 'identificationModule': {'nctId': 'NCT01879761', 'briefTitle': 'Immune Resolution After Staphylococcus Aureus Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'orgStudyIdInfo': {'id': '13-0491'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunosuppressed', 'description': 'Immunosuppressed includes patients with any one of the following:\n\n1. a diagnosis of a hematological malignancy\n2. a diagnosis of HIV\n3. myelosuppressive chemotherapy in the previous 90 days\n4. immune-modulating medications in the previous 90 days'}, {'label': 'Non-Immunosuppressed', 'description': 'Subject does not fit immunosuppressed criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}