Procalcitonin-guided antibiotic therapy in patients with fever in a general emergency department population: a multicenter noninferiority randomized clinical trial (HiTEMP study).

Link to article at PubMed

Procalcitonin-guided antibiotic therapy in patients with fever in a general emergency department population: a multicenter noninferiority randomized clinical trial (HiTEMP study).

Clin Microbiol Infect. 2018 Jun 02;:

Authors: van der Does Y, Limper M, Jie KE, Schuit SCE, Jansen H, Pernot N, van Rosmalen J, Poley MJ, Ramakers C, Patka P, van Gorp ECM, Rood PPM

Abstract
OBJECTIVES: Overuse of broad-spectrum antibiotics in emergency departments(EDs) results in antibiotic resistance. We determined if procalcitonin(PCT)-guided therapy can be used to reduce antibiotic regimens in EDs by investigating efficacy, safety and accuracy.
METHODS: This was a noninferiority multicenter randomized clinical trial, performed in two Dutch hospitals. Adult patients with fever ≥38.2°C(100.8°F) in triage were randomized between standard diagnostic workup(control group) and PCT-guided therapy, defined as standard workup with addition of one single PCT measurement. Treatment algorithm encouraged withholding antibiotic regimens with PCT<0.5μg/L, and starting antibiotic regimens PCT≥0.5μg/L. Exclusion criteria were immunocompromised conditions, pregnancy, moribund patients, patients <72h after surgery or requiring primary surgical intervention. Primary outcomes were efficacy, defined as number of prescribed antibiotic regimens; safety, defined as combined-safety-endpoint(CSE) consisting of 30-days mortality, intensive-care unit admission, ED-return-visit within 2 weeks; accuracy, defined as sensitivity, apecificity and area-under-the-curve(AUC) of PCT for bacterial infections. Noninferiority margin for safety outcome was 7.5%.

RESULTS: Between August 2014 and January 2017, 551 patients were included. In the PCT-guided group(n=275) 200(73%)patients were prescribed antibiotic regimens, in the control group(n=276) 212(77%)(p=0.28). There was no significant difference in CSE between the PCT-guided group, 29(11%), and control group, 46(16%)(p=0.16), with a noninferiority margin of 0.46%(n=526). AUC for confirmed bacterial infections for PCT was 0.681(95%CI0.633-0.730), for CRP 0.619(95%CI 0.569-0.669).: CONCLUSIONS.: PCT-guided therapy was noninferior in terms of safety, but did not reduce prescription of antibiotic regimens in an ED population with fever. In this heterogeneous population, the accuracy of PCT in diagnosing bacterial infections was poor. TRIAL REGISTRATION IN NETHERLANDS TRIAL REGISTER: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4949.

PMID: 29870855 [PubMed - as supplied by publisher]

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