Pancreatic Antibiotic Concentration Evaluation Assessment (PANACEA)

Brno University Hospital

Status: Active, not recruiting

Conditions: Acute Pancreatitis; Acute Pancreatic Fluid Collection

Study type: Observational

Funder types: Other

Identifiers

NCT07084428

BrnoUH2024

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Meropenem Group

Description:

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

Description:

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).