Staphylococcus Aureus Bacteraemia (SAB)-Support-Study

Staphylococcus Aureus Bacteremia Clinical Trial

— SABOT  

Official title:

SAB-Support-Study: Can Checklist-based Phone Calls Improve the Quality of Staphylococcus Aureus Bacteraemia (SAB) Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249451
• Other study ID #: BB 140/23
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: April 23, 2025

Study information

• Verified date: January 2024
• Source: University Medicine Greifswald
• Contact: Lena Ulm
• Phone: 00493834865569
• Email: lena.ulm[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

In addition, the effects of telephone consultation on the clinical outcome of patients will be examined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 23, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcal Infections
• Staphylococcus Aureus Bacteremia

Intervention

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.

Locations

Country	Name	City	State
Germany	Greifswald University Medicine	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	Time to specific antimicrobial treatment according to guidelines concerning agent and duration		Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	Time to negativity of follow up blood cultures		Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
Secondary	Time till TEE is performed (when indicated)		Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	Length of hospital stay after SAB diagnosis		Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)
Secondary	In-hospital mortality (all patients)		Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	In-hospital mortality (because of SAB complications)		Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	Hospital readmission until day 30 after SAB diagnosis (all patients)		Day of SAB diagnosis until day 30 after diagnosis
Secondary	Hospital readmission until day 30 after SAB diagnosis (because of SAB complications)		Day of SAB diagnosis until day 30 after diagnosis
Secondary	Hospital readmission until day 90 after SAB diagnosis (all patients)		Day of SAB diagnosis until day 90 after diagnosis
Secondary	Hospital readmission until day 90 after SAB diagnosis (because of SAB complications)		Day of SAB diagnosis until day 90 after diagnosis
Secondary	90-day all-cause mortality		Day of SAB diagnosis until day 90 after diagnosis
Secondary	90-day mortality because of SAB complications		Day of SAB diagnosis until day 90 after diagnosis
Secondary	Relapse of bacteremia until day 90 after diagnosis		Day of SAB diagnosis until day 90 after diagnosis
Secondary	Quality of discharge summary (documentation and treatment plan), calculated as a sum score		Hospital admission until hospital discharge (no later than day 90 after diagnosis)
Secondary	Infectious diseases consultation, when indicated (yes/no)		Hospital admission until hospital discharge (no later than day 90 after diagnosis)