Staphylococcus Aureus Bacteraemia (SAB)-Support-Study (SABOT)

November 17, 2025 updated by: University Medicine Greifswald

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Greifswald, Germany
        • Greifswald University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
  1. Drawing of follow-up blood cultures 2-3 days after start of adequate antibiotic therapy
  2. Early source control (removal of infected material or drainage of an abscess ≤ 72 hrs)
  3. Adequate search for SAB focus and metastatic manifestations
  4. TEE in patients with clinical indications (within 4 days of SAB diagnosis)
  5. Early start of specific therapy after receipt of results via phone call (≤12 hrs)
  6. Adequate dosage of antibiotic
  7. Sufficient duration of therapy (at least 14 d for uncomplicated bacteremia and 28 d for complicated bacteremia)
  8. Combination therapy with Rifampicin or Fosfomycin, when indicated
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Actual)

November 19, 2024

Study Completion (Actual)

January 18, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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