6/30/23, 2:15 AM TARGET (sepsis) Pathway Feedback Search Clinical Topics Home Studies TARGET (sepsis) TARGET (sepsis) Disease Sepsis and septic shock Trial question Is therapeutic drug monitoring superior to continuous infusion of piperacillin/tazobactam in patients with sepsis? Study design Multi-center Single blinded RCT Population Characteristics of study participants 31.0% female N = 249 69.0% male 249 patients (77 female, 172 male) Inclusion criteria: adult patients with sepsis Key exclusion criteria: contraindications to the study drug; impaired liver function; palliative care only; pregnancy; first measurement of piperacillin concentration not possible within 24 hours after randomization Interventions N=125 therapeutic drug monitoring (continuous infusion with dosing guided by daily therapeutic drug monitoring of piperacillin) N=124 fixed dose (continuous infusion with a fixed dose of 13.5 g/day) https://web.pathway.md/studies/reclPvIUAxVaOGjGL 1/2 6/30/23, 2:15 AM TARGET (sepsis) Pathway Primary outcome Mean of daily total sequential organ failure assessment score up to day 10 8.2 points 8.2 7.9 6.1 points 4.1 points 2.0 points No significant difference 0.0 points Therapeutic drug monitoring Fixed dose No significant difference in mean of daily total sequential organ failure assessment score up to day 10 (7.9 points vs. 8.2 points; AD 0.3 points, 95% CI -0.4 to 1) Secondary outcomes No significant difference in death at day 28 (21.6% vs. 25.8%; RR 0.8, 95% CI 0.5 to 1.3) No significant difference in clinical cure (35.6% vs. 17.4%; OR 1.9, 95% CI 0.5 to 6.2) No significant difference in microbiological cure (56.3% vs. 46%; OR 2.4, 95% CI 0.7 to 7.4) Safety outcomes No significant difference in adverse events. Conclusion In adult patients with sepsis, therapeutic drug monitoring was not superior to fixed dose with respect to mean of daily total sequential organ failure assessment score up to day 10. Reference Stefan Hagel, Friedhelm Bach, Thorsten Brenner et al. Effect of therapeutic drug monitoring-based dose optimization of piperacillin/tazobactam on sepsis-related organ dysfunction in patients with sepsis: a randomized controlled trial. Intensive Care Med. 2022 Mar;48(3):311-321. Open reference URL https://web.pathway.md/studies/reclPvIUAxVaOGjGL 2/2