Cefuroxime and Piperacillin Concentrations in the Biliary System

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002629-95-DK

Enrollment

200

Registered

2022-06-23

Start date

2022-08-02

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection in the biliary system such as cholecystitis and cholangitis both as acute infections and post-operative infections. MedDRA version: 20.0 Level: LLT Classification code 10008618 Term: Cholecystitis chronic NOS System Organ Class: 100000004871 MedDRA version: 20.0 Level: LLT Classification code 10008615 Term: Cholecystitis acute NOS System Organ Class: 100000004871 MedDRA version: 20.0 Level: LLT Classification code 10008619 Term: Cholecystitis NOS System Organ Class: 100000004871 Me

Interventions

Trade Name: Piperacillin Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: Piperacillin Other descriptive name: Piperacillin/Tazobactam Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed consent form - Planned endoscopic retrograde cholangiopancreaticography (ERCP) at Lillebaelt Hospital or Aalborg Univeristy Hospital - Age above 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Diabetes - Impaired kidneyfunction (eGFR < 60) - Allergic to beta-lactam antibiotics - On-going treatment with antibiotics on the day of the ERCP - Positive culture that requires treatment with another kind of antibiotics - Pregnancy - all fertile women must have performed a urinary-hCG test performed on the day of the ERCP as well as they are required to use contraceptives during the study and as long as there is a systemic exposure of the trial drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the concentration of cefuroxime and piperacillin in bile samples collected during ERCP and compare it to the concentration found in plasma.;Secondary Objective: - To investigate when the maximum concentration (Cmax) is reached in bile compared to plasma. - Time above the minimal inhibatory concentration (MIC);Primary end point(s): - Time above the minimal inhibatory concentration - Penetration of cefuroxime and piperacillin in bile;Timepoint(s) of evaluation of this end point: The end points will be evaluated at the end of the study	—

Measure

Time frame

Main Objective: To investigate the concentration of cefuroxime and piperacillin in bile samples collected during ERCP and compare it to the concentration found in plasma.;Secondary Objective: - To investigate when the maximum concentration (Cmax) is reached in bile compared to plasma. - Time above the minimal inhibatory concentration (MIC);Primary end point(s): - Time above the minimal inhibatory concentration - Penetration of cefuroxime and piperacillin in bile;Timepoint(s) of evaluation of this end point: The end points will be evaluated at the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Area under the concentration-time curve (AUC) - Half time (T½) - The maximal concentration (Cmax) - Time to Cmax (Tmax);Timepoint(s) of evaluation of this end point: The end points will be evaluated at the end of the study	—

Countries

Denmark

Contacts

Public ContactLouise Lerche Pontoppidan

Surgical department, Lillebaelt Hospital

louise.lerche.pontoppidan2@rsyd.dk004527124689

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026