SABATO
Trial question
Is early oral switch antimicrobial therapy noninferior to intravenous standard therapy in patients with low-risk S. aureus bloodstream infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 213
213 patients (65 female, 148 male).
Inclusion criteria: patients with low-risk S. aureus bloodstream infection after 5-7 days of intravenous antimicrobial therapy.
Key exclusion criteria: signs and symptoms of complicated S. aureus bloodstream infection; non-removable foreign devices; severe comorbidity.
Interventions
N=108 oral switch therapy (oral TMP/SMX 160/800 mg BID, or clindamycin 600 mg TID, or linezolid 600 mg BID).
N=105 intravenous standard therapy (intravenous flucloxacillin 2 g QID, or cefazolin 2 g TID, or vancomycin 1 g BID, or daptomycin 6-10 mg/kg daily).
Primary outcome
Rate of Staphylococcus aureus bacteremia-related complication within 90 days
13%
12.4%
13.0 %
9.8 %
6.5 %
3.3 %
0.0 %
Oral switch
therapy
Intravenous standard
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of S. aureus bacteremia-related complication within 90 days (13% vs. 12.4%; AD 0.7%, 95% CI -7.8 to 9.1).
Secondary outcomes
No significant difference in length of hospital stay from S. aureus bacteremia onset (12 days vs. 16 days; AD -3.1 days, 95% CI -7.5 to 1.4).
No significant difference in complications of intravenous administration (9.3% vs. 17%; ARD -7.9, 95% CI -17.6 to 1.9).
No significant difference in C. difficile infection (2% vs. 2%; ARD -0.001, 95% CI -3.8 to 3.7).
Safety outcomes
No significant differences in adverse and serious adverse events, infections and infestations.
Conclusion
In patients with low-risk S. aureus bloodstream infection after 5-7 days of intravenous antimicrobial therapy, oral switch therapy was noninferior to intravenous standard therapy with respect to the rate of S. aureus bacteremia-related complication within 90 days.
Reference
Achim J Kaasch, Luis Eduardo López-Cortés, Jesús Rodríguez-Baño et al. Efficacy and safety of an early oral switch in low-risk Staphylococcus aureus bloodstream infection (SABATO): an international, open-label, parallel-group, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2024 May;24(5):523-534.
Open reference URL