6/29/23, 1:45 AM PRORATA Pathway Feedback Search Clinical Topics Home Studies PRORATA PRORATA Trial question Is procalcitonin-guided strategy noninferior to standard guidelines of antibiotic treatment among patients ICU? Study design Multi-center Open label RCT Population Characteristics of study participants 33.7% female N = 630 66.3% male 630 patients (210 female, 411 male) Inclusion criteria: critically ill patients in ICU with suspected bacterial infections Key exclusion criteria: age < 18 years; known pregnancy; expected stay in the ICU < 3 days; bone-marrow transplant or chemotherapy induced neutropenia; infections for which long-term antibiotic treatment is strongly recommended poor chance of survival Interventions N=311 procalcitonin-guided antibiotic discontinuation (predefined algorithms to start or discontinue antibiotics according to serum procalcitonin concentrations) N=319 usual care (recommendations for duration of antimicrobial treatment derived from international and local guidelines) Primary outcome Death at days 28 21.2 % 21.2 20.4 15.9 % 10.6 % https://web.pathway.md/studies/recaqB7est4S6rEY3 1/2 6/29/23, 1:45 AM 10.6 % PRORATA Pathway Difference not exceeding nonferiority margin 5.3 % 0.0 % Procalcitonin-guided antibiotic discontinuation Usual care Difference not exceeding nonferiority margin in death at days 28 (21.2% vs. 20.4%; AD 0.8%, 90% CI -4.6 to 6.2) Secondary outcomes Significant increase in days without antibiotics by day 28 (14.3 vs. 11.6; AD 2.7, 95% CI 1.4 to 4.1) Conclusion In critically ill patients in ICU with suspected bacterial infections, procalcitonin-guided antibiotic discontinuation was noninferior to usual care with respect to death at days 28. Reference Bouadma L, Luyt CE, Tubach F et al. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. Open reference URL https://web.pathway.md/studies/recaqB7est4S6rEY3 2/2