Pancreatic Antibiotic Concentration Evaluation Assessment (PANACEA)

This observational study aims to evaluate the penetration of intravenously administered antibiotics into pancreatic fluid collections in patients with suspected infected walled-off pancreatic necrosis (WOPN). In selected patients undergoing percutaneous or endoscopic drainage of the collection as part of their clinical care, a small sample of pancreatic fluid will be collected and analyzed to determine the concentration of the administered antibiotic.

At the same time, a blood sample will be taken to assess the antibiotic concentration in plasma. By comparing the concentrations in pancreatic fluid and plasma, the study seeks to determine the extent to which different antibiotics (e.g., meropenem or piperacillin-tazobactam) reach the site of infection within the pancreas.

All procedures performed as part of the study, with the exception of the antibiotic concentration measurement, are standard components of routine care for patients with complicated acute pancreatitis. Participation in the study does not alter the diagnostic or therapeutic management of the patient. Patients provide written informed consent before enrollment.

The results of this study may help optimize antibiotic dosing in patients with infected pancreatic collections and contribute to more effective and individualized treatment strategies in the future.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pancreatitis; Acute Pancreatic Fluid Collection

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 62500
      • Fakultní nemocnice Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients hospitalized with past or ongoing acute pancreatitis undergoing drainage or puncture of suspected infected pancreatic fluid collection. Patients are recruited from the University Hospital Brno. Approximately 40 participants are expected.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Signed informed consent
• Undergoing percutaneous or endoscopic drainage/puncture of a pancreatic fluid collection

Exclusion Criteria:

- Failure or refusal to sign informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Meropenem Group; Patients with WOPN receiving intravenous meropenem. Serial blood and pancreatic fluid samples were collected to assess drug penetration and pharmacokinetics as part of therapeutic drug monitoring (TDM).
Piperacillin Group; Patients with WOPN receiving intravenous piperacillin-tazobactam. Serial blood and pancreatic fluid samples were collected to evaluate drug penetration and pharmacokinetics as part of therapeutic drug monitoring (TDM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic concentration ratio between pancreatic fluid and plasma	Ratio of antibiotic concentration in pancreatic fluid (WOPN) to plasma concentration, determined from simultaneously collected samples after intravenous antibiotic administration	Within 6 hours after antibiotic administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured concentrations of antibiotics in pancreatic fluid and plasma	Absolute concentrations of meropenem and piperacillin in pancreatic fluid and plasma from simultaneously collected samples.	Within 6 hours after antibiotic administration

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: July 17, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute pancreatis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: BrnoUH2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No