Siriwardena, Ajith K., Jegatheeswaran, Santhalingam and Mason, James (2022) A procalcitonin-based algorithm to guide antibiotic use in patients with acute pancreatitis (PROCAP) : a single-centre, patient-blinded, randomised controlled trial. The Lancet Gastroenterology & Hepatology, 7 (10). pp. 913-921. doi:10.1016/S2468-1253(22)00212-6 ISSN 2468-1253.

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Abstract

Background:
Differentiating inflammation from bacterial infection in acute pancreatitis can be difficult.
Procalcitonin (PCT) can distinguish infection from inflammation and algorithms based on PCT measurement can differentiate bacterial sepsis from a systemic inflammatory response. The PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP) randomized trial tests the hypothesis that a PCT-based algorithm to guide initiation, continuation and discontinuation of antibiotics will lead to reduced antibiotic use without an adverse effect on outcome.

Methods:
PROCAP is a single-centre randomised controlled trial of patients with acute pancreatitis assigned to procalcitonin-guided care or usual care. The primary outcome was use of antibiotics during the index admission. Secondary outcomes included mortality (safety endpoint), days of antibiotic use, infections, interventions, length of stay, readmission, health-related quality of life (QoL) and cost up to 90 days.

Findings:
From 29th July 2018 to 13th November 2020, 260 patients were recruited. 132 received procalcitonin-guided care and 128 usual care. Antibiotics were used during the index admission in 44.7% patients assigned to procalcitonin-guided care and in 61.7% assigned to usual care; risk difference (adjusted): -15.6% (95%CI: -27.0% to -4.2%), p=0.007. Treatment effect odds ratio is 0.49 (95%CI: 0.29 to 0.83), p=0.008. Procalcitonin-guided care reduced the average number of days of antibiotic use per patient from 5.8 to 4.5 days, mean difference (adjusted): ‑1.16, (95%CI: -2.10 to -0.22), p=0.015. There were no differences in mortality, infections, adverse events, length of stay, QoL or cost.

Interpretation:
This trial found that procalcitonin-guided care reduced antibiotic use without increasing infection or harm in patients with acute pancreatitis. ISRCTN 50584992.

Funding:
There was no external funding for this study.

Item Type:	Journal Article
Subjects:	Q Science > QP Physiology R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Pancreatitis, Pancreatitis -- Treatment, Antibiotics , Calcitonin, Pancreas -- Diseases
Journal or Publication Title:	The Lancet Gastroenterology & Hepatology
Publisher:	Elsevier
ISSN:	2468-1253
Official Date:	1 October 2022
Dates:	Date Event 1 October 2022 Published 19 July 2022 Available 11 July 2022 Accepted
Volume:	7
Number:	10
Page Range:	pp. 913-921
DOI:	10.1016/S2468-1253(22)00212-6
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Date of first compliant deposit:	20 July 2022
Date of first compliant Open Access:	19 January 2023
Contributors:	Contribution Name Contributor ID Research Group PROCAP investigators, UNSPECIFIED

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