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Precision use of Antibiotics in Infected Necrotizing Pancreatitis

Precision use of Antibiotics in Infected Necrotizing Pancreatitis - PIANO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56749
Enrollment
288
Registered
2024-05-14
Start date
2024-11-08
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute necrotizing pancreatitis

Interventions

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

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Hospitalized patient diagnosed with acute pancreatitis according to the  revised Atlanta classification  - Signs of pancreatic or peripancreatic necrosis on imaging - Written informed consent

Exclusion criteria

Exclusion criteria: - Patients with a current pancreatic carcinoma - Patients with (an acute flare-up of) chronic pancreatitis according to the  M-ANNHEIM criteria

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a composite of mortality and major complications between index admission and 6 months follow-up. Major complications are defined as new onset organ failure and necessity of invasive intervention(s) for infected pancreas necrosis.

Secondary

MeasureTime frame
Secondary endpoints include antimicrobial use, infections with multi-drug resistant microorganisms, development of major infections and other complications, health care utilization, quality of life and cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)