Pancreatic Antibiotic Concentration Evaluation Assessment

NCT07084428 | Active Not Recruiting

• 1 other identifier: BrnoUH2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis; Acute Pancreatic Fluid Collection

Keywords

acute pancreatis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measured concentrations of antibiotics in pancreatic fluid and plasma

  Within 6 hours after antibiotic administration

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Failure or refusal to sign informed consent

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Fakultni nemocnice Brno

Brno, Czech Republic, 62500, Czechia

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: January 15, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CZ (1)