PRORATA

PRORATA

Is procalcitonin-guided strategy noninferior to standard guidelines of antibiotic treatment among patients ICU?

Study design

Population

• 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

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% Cl 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.