Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06249451
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2024-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Staphylococcus Aureus Bacteraemia (SAB)-Support-Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'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': 'D018805', 'term': 'Sepsis'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOP adherence, calculated as a sum score per patient with the following 8 parameters:', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)', 'description': '1. Drawing of follow-up blood cultures 2-3 days after start of adequate antibiotic therapy\n2. Early source control (removal of infected material or drainage of an abscess ≤ 72 hrs)\n3. Adequate search for SAB focus and metastatic manifestations\n4. TEE in patients with clinical indications (within 4 days of SAB diagnosis)\n5. Early start of specific therapy after receipt of results via phone call (≤12 hrs)\n6. Adequate dosage of antibiotic\n7. Sufficient duration of therapy (at least 14 d for uncomplicated bacteremia and 28 d for complicated bacteremia)\n8. Combination therapy with Rifampicin or Fosfomycin, when indicated'}], 'secondaryOutcomes': [{'measure': 'Time to specific antimicrobial treatment according to guidelines concerning agent and duration', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'Time to negativity of follow up blood cultures', 'timeFrame': 'Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'Time till TEE is performed (when indicated)', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'Length of hospital stay after SAB diagnosis', 'timeFrame': 'Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'In-hospital mortality (all patients)', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'In-hospital mortality (because of SAB complications)', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'Hospital readmission until day 30 after SAB diagnosis (all patients)', 'timeFrame': 'Day of SAB diagnosis until day 30 after diagnosis'}, {'measure': 'Hospital readmission until day 30 after SAB diagnosis (because of SAB complications)', 'timeFrame': 'Day of SAB diagnosis until day 30 after diagnosis'}, {'measure': 'Hospital readmission until day 90 after SAB diagnosis (all patients)', 'timeFrame': 'Day of SAB diagnosis until day 90 after diagnosis'}, {'measure': 'Hospital readmission until day 90 after SAB diagnosis (because of SAB complications)', 'timeFrame': 'Day of SAB diagnosis until day 90 after diagnosis'}, {'measure': '90-day all-cause mortality', 'timeFrame': 'Day of SAB diagnosis until day 90 after diagnosis'}, {'measure': '90-day mortality because of SAB complications', 'timeFrame': 'Day of SAB diagnosis until day 90 after diagnosis'}, {'measure': 'Relapse of bacteremia until day 90 after diagnosis', 'timeFrame': 'Day of SAB diagnosis until day 90 after diagnosis'}, {'measure': 'Quality of discharge summary (documentation and treatment plan), calculated as a sum score', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}, {'measure': 'Infectious diseases consultation, when indicated (yes/no)', 'timeFrame': 'Hospital admission until hospital discharge (no later than day 90 after diagnosis)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'Bacteremia'], 'conditions': ['Staphylococcus Aureus Bacteremia']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to investigate whether checklist-based close telephone consultation and process surveillance for S. aureus bacteraemia (SAB) can improve adherence to our in-house SAB-guidelines (prospective quality- improvement group).\n\nIn addition, the effects of telephone consultation on the clinical outcome of patients will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* Inpatient treatment at the University Medicine Greifswald university hospital\n* First diagnosis of SAB in hospital\n\nExclusion Criteria:\n\n* SAB already known before admission\n* Palliative management within 48 hrs after SAB diagnosis\n* Death within 48 hrs after SAB diagnosis\n* Hospital discharge within 48hrs after SAB diagnosis'}, 'identificationModule': {'nctId': 'NCT06249451', 'acronym': 'SABOT', 'briefTitle': 'Staphylococcus Aureus Bacteraemia (SAB)-Support-Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'SAB-Support-Study: Can Checklist-based Phone Calls Improve the Quality of Staphylococcus Aureus Bacteraemia (SAB) Management', 'orgStudyIdInfo': {'id': 'BB 140/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Retrospective control group (n= 62)', 'description': 'Analysis of patients with the diagnosis of S. aureus-bacteraemia between 01.10.2022-01.10.2023'}, {'type': 'OTHER', 'label': 'Prospective quality-improvement group (n= 62)', 'description': 'Analysis of patients with the diagnosis of S. aureus-bacteraemia between 22.01.2024-22.01.2025', 'interventionNames': ['Other: Checklist-based phone calls']}], 'interventions': [{'name': 'Checklist-based phone calls', 'type': 'OTHER', 'description': 'The treating doctor will be called on day 1 and 12 after SAB diagnosis to point out the standard of care (as per our evidence-based in-hospital standard operating procedure (SOP)) for SAB.\n\nOn day 2 and 6 after SAB diagnosis, there will be additional phone calls if clinical management does not follow hospital guidelines.\n\nThe study team will also leave comments in the medical charts of the respective patients if the management does not follow hospital guidelines.', 'armGroupLabels': ['Prospective quality-improvement group (n= 62)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Greifswald', 'country': 'Germany', 'facility': 'Greifswald University Medicine', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}