6/29/23, 11:57 PM STRIVE Pathway Feedback Search Clinical Topics Home Studies STRIVE STRIVE Disease Disease Low back pain Surgical site infection Trial question What is the effect of a four-antigen S. aureus vaccine in patients undergoing elective spinal fusion surgical procedures? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.0% female N = 3450 45.0% male 3450 patients (1907 female, 1543 male) Inclusion criteria: patients aged 18-85 years scheduled to undergo elective spinal fusion surgical procedures Key exclusion criteria: surgical indication of malignancy; infection, or acute or emergency trauma; major surgery within 3 months prior to enrolment; spinal surgery performed within 6 months prior to study enrolment; congenital or acquired immunodeficiency disorder Interventions N=1726 S. aureus four-antigen vaccine (four-antigen S. aureus vaccine 10-60 days before surgery) N=1724 placebo (sterile water injection 10-60 days before surgery) https://web.pathway.md/studies/recRwFHoTCFe5I85z 1/2 6/29/23, 11:57 PM STRIVE Pathway Primary outcome Staphylococcus aureus blood stream infection 0.7 % 0.7 0.5 % 0.5 0.3 % 0.2 % No significant difference 0.0 % Staphylococcus aureus four-antigen vaccine Placebo No significant difference in S. aureus blood stream infection (0.5% vs. 0.7%; AD -0.2%, 95% CI -0.4 to 0) Secondary outcomes No significant difference in S. aureus surgical site infection (1.6% vs. 1.4%; AD 0.2%, 95% CI -0.37 to 0.77) Safety outcomes No significant differences in adverse events, systemic events. Conclusion In patients aged 18-85 years scheduled to undergo elective spinal fusion surgical procedures, S. aureus four-antigen vaccine was not superior to placebo with respect to S. aureus blood stream infection. Reference Hamid Hassanzadeh, James Baber, Elizabeth Begier et al. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STRIVE Randomized Clinical Trial. Clin Infect Dis. 2023 May 1;ciad218. Open reference URL https://web.pathway.md/studies/recRwFHoTCFe5I85z 2/2