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
34.0% female
66.0% male
N = 621
621 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=307 procalcitonin-guided antibiotic discontinuation (predefined algorithms to start or discontinue antibiotics according to serum procalcitonin concentrations).
N=314 usual care (recommendations for duration of antimicrobial treatment derived from international and local guidelines).
Primary outcome
Death at days 28
21.2%
20.4%
21.2 %
15.9 %
10.6 %
5.3 %
0.0 %
Procalcitonin-guided antibiotic
discontinuation
Usual
care
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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).
No significant difference in relapse (6.5% vs. 5.1%).
No significant difference in the rate of number of days without mechanical ventilation (11.1% vs. 10.9%).
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.
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