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PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): study protocol for a randomised

Ajith K Siriwardena1,2, Santhalingam Jegatheeswaran3, James M Mason4

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This study investigates using procalcitonin (PCT) algorithms to reduce antibiotic use in acute pancreatitis patients. The PROCAP trial aims to decrease antibiotic prescriptions without negatively impacting patient outcomes.

Keywords:
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Area of Science:

  • Clinical Medicine
  • Infectious Diseases
  • Gastroenterology

Background:

  • Distinguishing infection from inflammation in acute pancreatitis is challenging, often leading to antibiotic overuse.
  • Procalcitonin (PCT) levels rise with bacterial infection and can guide antibiotic therapy.
  • Current diagnostic methods may not reliably differentiate bacterial sepsis from systemic inflammatory response in pancreatitis.

Purpose of the Study:

  • To test if a procalcitonin (PCT)-based algorithm reduces antibiotic use in acute pancreatitis.
  • To evaluate the safety and cost-effectiveness of PCT-guided antibiotic strategies.
  • To compare PCT-guided antibiotic decisions against standard care in acute pancreatitis management.

Main Methods:

  • A single-centre, randomised, controlled, single-blind, pragmatic trial (PROCAP).
  • 200 patients with acute pancreatitis allocated 1:1 to PCT-guided or standard antibiotic care.
  • Primary outcome: antibiotic use during index admission; secondary outcomes include mortality, infection rates, and costs.

Main Results:

  • Primary outcome measure is the binary outcome of antibiotic use during index admission.
  • Secondary outcome measures include safety endpoints like all-cause mortality and clinical infections.
  • The study aims to recruit 200 patients to detect a 20% absolute change in antibiotic use.

Conclusions:

  • The PROCAP trial is the largest randomised trial assessing PCT algorithms for antibiotic use in acute pancreatitis.
  • It is the first randomised trial comparing PCT-guided antibiotic decisions to standard care based on international guidelines.
  • Results will inform optimal antibiotic stewardship in acute pancreatitis.