Precision use of Antibiotics in Infected Necrotizing Pancreatitis

Antimicrobial treatment is a key part of treatment of infected necrotizing
pancreatitis (IPN), alongside supportive care and drainage interventions.
There are, however, no recommendations in current guidelines regarding the
choice, timing and duration of antimicrobials for IPN. A recent observational
cohort study showed that antimicrobial treatment for patients with necrotizing
pancreatitis is currently very heterogeneous and often inappropriate. The
antimicrobial stewardship approach aims to improve the quality of antimicrobial
use in order to improve patient outcomes, curb the rapidly growing rise in
antimicrobial resistance and reduce unnecessary costs. A best-practice protocol
based on current evidence and antimicrobial stewardship principles is expected
to lead to more appropriate use of antibiotics in patients with (infected)
necrotizing pancreatitis.

The primary objective is to determine whether implementation of a best-practice
protocol focused on antimicrobial stewardship in Dutch hospitals is
non-inferior compared to standard care on mortality and major complications in
patients with acute necrotizing pancreatitis.

A nationwide, noninferiority, parallel group, cluster-randomized trial.
Aproximately 30 clusters of at least two hospitals will be randomized to the
intervention (a best-practice protocol focussed on antimicrobial stewardship)
or usual care in a 1:1 allocation ratio.

Implementation of a best-practice protocol on cluster level, targeted at
clinical staff involved in the treatment of necrotizing pancreatitis. During a
two-month transition phase, intervention clusters will engage in the
implementation procedure including educational and consensus meetings, an
e-learning platform and clinical decision tool. The best-practice protocol
consists of recommendations to improve and standardize the antimicrobial
treatment strategy for necrotizing pancreatitis. These recommendations are
based on antimicrobial stewardship principles, the best available evidence and
a worldwide Delphi consensus survey. A final component of the intervention is
the evaluation of the implementation strategy and assessment of compliance with
the best-practice protocol.

Due to the intervention at cluster level, patients are not directly involved in
the trial. The burden of participation concerns the time investment that is
necessary to the complete these questionnaires. No additional interventions or
tests associated with participation in the study. The anticipated benefits of
the best-practice protocol include a reduced risk of colonization and infection
with multi-drug resistant microorganisms, shorter hospital stay and less
invasive interventions due to more successful conservative management of
infected necrotizing pancreatitis.