Pancreatic Antibiotic Concentration Evaluation Assessment

NCT ID: NCT07084428

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pancreatic Fluid Collection Acute Pancreatitis

Keywords

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acute pancreatis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Harazim

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fakultni nemocnice Brno

Brno, Czech Republic, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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BrnoUH2024

Identifier Type: -

Identifier Source: org_study_id