Procalcitonin algorithm reduced antibiotic use in patients with acute pancreatitis
A randomized trial assigned some patients to a treatment strategy of starting, stopping, or continuing antibiotics based on whether their procalcitonin test value was more or less than 1.0 ng/mL.
A treatment algorithm based on procalcitonin level was associated with reduced antibiotic use, without increasing infection or harm, in patients with acute pancreatitis, a recent trial found.
Researchers conducted the PROCAP (PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis) trial at a U.K. hospital. They randomly assigned patients with a clinical diagnosis of acute pancreatitis to receive procalcitonin-guided care or usual care, stratifying the randomization sequence by disease severity and admission pathway. Patients, but not clinicians, were blinded to group assignment. In the procalcitonin-guided care group, procalcitonin testing was conducted on days 0, 4, 7, and weekly thereafter. Guidance was to stop or not start antibiotics following a test value of less than 1.0 ng/mL and to start or continue antibiotics following a test value of 1.0 ng/mL or greater. Measurement of procalcitonin preceded any empirical clinical decision to use antibiotics in the intervention group; otherwise, both groups received standard care. The primary outcome was use of antibiotics during the index hospitalization, analyzed in the intention-to-treat population. Results were published July 18 by The Lancet Gastroenterology & Hepatology.
Three hundred sixty-nine patients were screened between July 29, 2018, and Nov. 13, 2020. A total of 260 patients were randomly assigned to a treatment group, 132 to procalcitonin-guided care and 128 to usual care. Fifty-nine (45%) patients in the procalcitonin-guided care group were prescribed antibiotics compared with 79 (63%) in the usual care group (adjusted risk difference, −15.6% [95% CI, −27.0% to −4.2%]; P=0.0071). The odds ratio for the treatment effect was 0.49 (95% CI, 0.29 to 0.83; P=0.0077). Sensitivity analyses of the primary outcome supported this finding. There was no significant difference between groups in the number of clinical infections or hospital-acquired infections per patient. Four (3%) patients in the procalcitonin group and three (2%) in the usual care group died of underlying severe pancreatitis. There was no difference in adverse events between groups.
The study was conducted at a single center, among other limitations, the authors noted. To date, PROCAP may be the largest randomized trial of the use of a procalcitonin algorithm to guide antibiotic use in patients with acute pancreatitis, they said.
“The results of this study are likely to lead to modifications of current practice and of recommendations in guidelines,” an accompanying comment said. “Future studies aiming to validate these results should also focus on the accuracy of procalcitonin for the detection of infection in patients with moderate to severe disease and on whether the procalcitonin-based algorithm should be used in all patients or only in some subgroups.”