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OpenTrials
Active, Not Recruiting

NCT Number: NCT07084428

Pancreatic Antibiotic Concentration Evaluation Assessment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fakultni nemocnice Brno

Brno, Czech Republic, 62500, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Antibiotic concentration ratio between pancreatic fluid and plasma

    Time frame: Within 6 hours after antibiotic administration

    Ratio of antibiotic concentration in pancreatic fluid (WOPN) to plasma concentration, determined from simultaneously collected samples after intravenous antibiotic administration

Secondary outcomes

  1. Measured concentrations of antibiotics in pancreatic fluid and plasma

    Time frame: Within 6 hours after antibiotic administration

    Absolute concentrations of meropenem and piperacillin in pancreatic fluid and plasma from simultaneously collected samples.

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Acronym: PANACEA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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