Staphylococcus Aureus Bacteraemia (SAB)-Support-Study

NCT06249451 | Completed

• 1 other identifier: BB 140/23
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Staphylococcus Aureus Bacteremia

Keywords

Staphylococcus aureus; Bacteremia

Outcome Measures

Primary Outcomes (1)

• SOP adherence, calculated as a sum score per patient with the following 8 parameters:

  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 Outcomes (15)

• Time to specific antimicrobial treatment according to guidelines concerning agent and duration

  Hospital admission until hospital discharge (no later than day 90 after diagnosis)

• Time to negativity of follow up blood cultures

  Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)

• Time till TEE is performed (when indicated)

  Hospital admission until hospital discharge (no later than day 90 after diagnosis)

• Length of hospital stay after SAB diagnosis

  Day of SAB diagnosis until hospital discharge (no later than day 90 after diagnosis)

• In-hospital mortality (all patients)

  Hospital admission until hospital discharge (no later than day 90 after diagnosis)

Study Arms (2)

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

Other: Checklist-based phone calls

Interventions

Checklist-based phone calls OTHER

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.

Prospective quality-improvement group (n= 62)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• Inpatient treatment at the University Medicine Greifswald university hospital
• First diagnosis of SAB in hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Greifswald University Medicine

Greifswald, Germany

Location

MeSH Terms

Conditions

Staphylococcal Infections; Bacteremia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 8, 2024
• Study Start: January 22, 2024
• Primary Completion: November 19, 2024
• Study Completion: January 18, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)