Staphylococcus Aureus BacteremiaSABOTNCT06249451
Staphylococcus Aureus Bacteraemia (SAB)-Support-Study
A study testing Checklist-based phone calls in people with Staphylococcus Aureus Bacteremia, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- What is being tested?
- Checklist-based phone calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2024to 18 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Inpatient treatment at the University Medicine Greifswald university hospital
- First diagnosis of SAB in hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Staphylococcus Aureus Bacteremia
- Being tested
- Checklist-based phone calls
- Keywords
- Staphylococcus aureus, Bacteremia
- Medical subject headings
- Staphylococcal Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist-based phone callsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective control group (n= 62) | No intervention | Analysis of patients with the diagnosis of S. aureus-bacteraemia between 01.10.2022-01.10.2023 |
| Prospective quality-improvement group (n= 62) | Other | Analysis of patients with the diagnosis of S. aureus-bacteraemia between 22.01.2024-22.01.2025 Receives: Other: Checklist-based phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOP adherence, calculated as a sum score per patient with the following 8 parameters:
- Drawing of follow-up blood cultures 2-3 days after start of adequate antibiotic therapy
- Early source control (removal of infected material or drainage of an abscess ≤ 72 hrs)
- Adequate search for SAB focus and metastatic manifestations
- TEE in patients with clinical indications (within 4 days of SAB diagnosis)
- Early start of specific therapy after receipt of results via phone call (≤12 hrs)
- Adequate dosage of antibiotic
- Sufficient duration of therapy (at least 14 d for uncomplicated bacteremia and 28 d for complicated bacteremia)
- Combination therapy with Rifampicin or Fosfomycin, when indicated
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary outcomes (15)
Time to specific antimicrobial treatment according to guidelines concerning agent and duration
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Time to negativity of follow up blood cultures
Measured: Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
Time till TEE is performed (when indicated)
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Length of hospital stay after SAB diagnosis
Measured: Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
In-hospital mortality (all patients)
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
In-hospital mortality (because of SAB complications)
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Hospital readmission until day 30 after SAB diagnosis (all patients)
Measured: Day of SAB diagnosis until day 30 after diagnosis
Hospital readmission until day 30 after SAB diagnosis (because of SAB complications)
Measured: Day of SAB diagnosis until day 30 after diagnosis
Hospital readmission until day 90 after SAB diagnosis (all patients)
Measured: Day of SAB diagnosis until day 90 after diagnosis
Hospital readmission until day 90 after SAB diagnosis (because of SAB complications)
Measured: Day of SAB diagnosis until day 90 after diagnosis
90-day all-cause mortality
Measured: Day of SAB diagnosis until day 90 after diagnosis
90-day mortality because of SAB complications
Measured: Day of SAB diagnosis until day 90 after diagnosis
Relapse of bacteremia until day 90 after diagnosis
Measured: Day of SAB diagnosis until day 90 after diagnosis
Quality of discharge summary (documentation and treatment plan), calculated as a sum score
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Infectious diseases consultation, when indicated (yes/no)
Measured: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start22 Jan 2024
- Primary completion19 Nov 2024
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249451
- Sponsor's protocol ID
- BB 140/23
- Acronym
- SABOT
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAB-Support-Study: Can Checklist-based Phone Calls Improve the Quality of Staphylococcus Aureus Bacteraemia (SAB) Management
- ClinicalTrials.gov ID
- NCT06249451
- Acronym / sponsor ID
- SABOT / BB 140/23
- Conditions
- Staphylococcus Aureus Bacteremia
- Keywords
- Staphylococcus aureus, Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective control group (n= 62) | No intervention | –Analysis of patients with the diagnosis of S. aureus-bacteraemia between 01.10.2022-01.10.2023 |
| Prospective quality-improvement group (n= 62) | Other | Other: Checklist-based phone callsAnalysis of patients with the diagnosis of S. aureus-bacteraemia between 22.01.2024-22.01.2025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- Inpatient treatment at the University Medicine Greifswald university hospital
- First diagnosis of SAB in hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist-based phone callsThe 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. | Other | Prospective quality-improvement group (n= 62) |
Primary outcome
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
15 secondary outcomes
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)
Time to negativity of follow up blood cultures
Time frame: 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)
Length of hospital stay after SAB diagnosis
Time frame: 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)
In-hospital mortality (because of SAB complications)
Time frame: 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
Hospital readmission until day 30 after SAB diagnosis (because of SAB complications)
Time frame: 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
Hospital readmission until day 90 after SAB diagnosis (because of SAB complications)
Time frame: 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
90-day mortality because of SAB complications
Time frame: 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
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)
Infectious diseases consultation, when indicated (yes/no)
Time frame: Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist-based phone calls in people with Staphylococcus Aureus Bacteremia, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.