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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Checklist-based phone calls

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BB 140/23

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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