- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249451
Staphylococcus Aureus Bacteraemia (SAB)-Support-Study (SABOT)
SAB-Support-Study: Can Checklist-based Phone Calls Improve the Quality of Staphylococcus Aureus Bacteraemia (SAB) Management
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).
In addition, the effects of telephone consultation on the clinical outcome of patients will be examined.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Greifswald, Germany
- Greifswald University Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years
- Inpatient treatment at the University Medicine Greifswald university hospital
- First diagnosis of SAB in hospital
Exclusion Criteria:
- SAB already known before admission
- Palliative management within 48 hrs after SAB diagnosis
- Death within 48 hrs after SAB diagnosis
- Hospital discharge within 48hrs after SAB diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Retrospective control group (n= 62)
Analysis of patients with the diagnosis of S. aureus-bacteraemia between 01.10.2022-01.10.2023
|
|
|
Other: Prospective quality-improvement group (n= 62)
Analysis of patients with the diagnosis of S. aureus-bacteraemia between 22.01.2024-22.01.2025
|
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. On day 2 and 6 after SAB diagnosis, there will be additional phone calls if clinical management does not follow hospital guidelines. The study team will also leave comments in the medical charts of the respective patients if the management does not follow hospital guidelines. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SOP adherence, calculated as a sum score per patient with the following 8 parameters:
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to specific antimicrobial treatment according to guidelines concerning agent and duration
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
Time to negativity of follow up blood cultures
Time Frame: Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
|
Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
|
|
Time till TEE is performed (when indicated)
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
Length of hospital stay after SAB diagnosis
Time Frame: Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
|
Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
|
|
In-hospital mortality (all patients)
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
In-hospital mortality (because of SAB complications)
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
Hospital readmission until day 30 after SAB diagnosis (all patients)
Time Frame: Day of SAB diagnosis until day 30 after diagnosis
|
Day of SAB diagnosis until day 30 after diagnosis
|
|
Hospital readmission until day 30 after SAB diagnosis (because of SAB complications)
Time Frame: Day of SAB diagnosis until day 30 after diagnosis
|
Day of SAB diagnosis until day 30 after diagnosis
|
|
Hospital readmission until day 90 after SAB diagnosis (all patients)
Time Frame: Day of SAB diagnosis until day 90 after diagnosis
|
Day of SAB diagnosis until day 90 after diagnosis
|
|
Hospital readmission until day 90 after SAB diagnosis (because of SAB complications)
Time Frame: Day of SAB diagnosis until day 90 after diagnosis
|
Day of SAB diagnosis until day 90 after diagnosis
|
|
90-day all-cause mortality
Time Frame: Day of SAB diagnosis until day 90 after diagnosis
|
Day of SAB diagnosis until day 90 after diagnosis
|
|
90-day mortality because of SAB complications
Time Frame: Day of SAB diagnosis until day 90 after diagnosis
|
Day of SAB diagnosis until day 90 after diagnosis
|
|
Relapse of bacteremia until day 90 after diagnosis
Time Frame: Day of SAB diagnosis until day 90 after diagnosis
|
Day of SAB diagnosis until day 90 after diagnosis
|
|
Quality of discharge summary (documentation and treatment plan), calculated as a sum score
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
|
Infectious diseases consultation, when indicated (yes/no)
Time Frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Hospital admission until hospital discharge (no later than day 90 after diagnosis)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB 140/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Staphylococcus Aureus Bacteremia
-
West Virginia UniversityEnrolling by invitationStaphylococcus Aureus BacteremiaUnited States
-
Intermountain Health Care, Inc.Not yet recruitingStaphylococcus Aureus BacteremiaUnited States
-
Todd C. Lee MD MPH FIDSAUniversity of Melbourne; The Peter Doherty Institute for Infection and ImmunityRecruitingStaphylococcus Aureus Bacteremia | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septicemia | S. Aureus Bacteremia | S. Aureus Bloodstream InfectionAustralia, Canada
-
Armata Pharmaceuticals, Inc.United States Department of DefenseCompletedBacteremia | Staphylococcus Aureus | Staphylococcus Aureus Bacteremia | Bacteremia Due to Staphylococcus Aureus | Bacteremia StaphUnited States, Australia
-
Forest LaboratoriesCompletedStaphylococcus Aureus Bacteremia | Methicillin-resistant Staphylococcus Aureus (MRSA) BacteremiaUnited States
-
McGill University Health Centre/Research Institute...University of MelbourneRecruitingStaphylococcus Aureus Bacteremia | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septicemia | S. Aureus Bacteremia | S. Aureus Bloodstream Infection | Staphylococcus Aureus Bloodstream InfectionCanada
-
University of MelbourneKing's College London; Radboud University Medical Center; Rambam Health Care... and other collaboratorsRecruitingStaphylococcus Aureus BacteremiaAustralia, United States, New Zealand, Canada, United Kingdom, Singapore, Sweden, Netherlands, France, Germany, Israel, South Africa, Japan
-
Region SkaneRecruitingStaphylococcal Bacteraemia | Staphylococcus (S.) Aureus Infection | Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia) | Staphylococcus Aureus BacteraemiaSweden
-
Todd C. Lee MD MPH FIDSARecruitingStaphylococcus Aureus Bacteremia | Staphylococcus Aureus Endocarditis | Staphylococcus Aureus Septicemia | Staphylococcal SepsisCanada
-
University of PennsylvaniaWithdrawnStaphylococcus Aureus Bacteremia | Staphylococcus Aureus EndocarditisUnited States
Clinical Trials on Checklist-based phone calls
-
University of Kansas Medical CenterCompletedBreast Cancer FemaleUnited States
-
University of PennsylvaniaCompleted
-
Centre Hospitalier Universitaire VaudoisCompletedDepression | Anxiety | Aging | Social IsolationSwitzerland
-
Carol Fabian, MDCompletedBreast Cancer FemaleUnited States
-
Brigham and Women's HospitalCompletedIn Vitro Fertilization | Psychological StressUnited States
-
The University of Texas Health Science Center,...Completed
-
University of ZurichCompletedChronic Depressive DisorderSwitzerland
-
Ohio State UniversityCompleted
-
Stanford UniversityActive, not recruitingParoxysmal Atrial FibrillationUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedPeripheral Arterial DiseaseUnited States