Cefuroxime and Piperacillin Concentrations in the Biliary System

Phase 1

• Conditions: Infection in the biliary system such as cholecystitis and cholangitis both as acute infections and post-operative infections.; MedDRA version: 20.0Level: LLTClassification code 10008618Term: Cholecystitis chronic NOSSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10008615Term: Cholecystitis acute NOSSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10008619Term: Cholecystitis NOSSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10004638Term: Bile duct stone with cholecystitisSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10007004Term: Calculus of gallbladder with acute cholecystitisSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10006995Term: Calculus of bile duct with acute cholecystitisSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10008606Term: Cholangitis acute NOSSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10008608Term: Cholangitis NOSSystem Organ Class: 100000004871; MedDRA version: 20.0Level: LLTClassification code 10008607Term: Cholangitis chronic NOSSystem Organ Class: 100000004871

• Registration Number: EUCTR2021-002629-95-DK
• Lead Sponsor: Department of vascular surgery, Lillebaelt Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- Time above the minimal inhibatory concentration (MIC);Primary end point(s): - Time above the minimal inhibatory concentration <br>- 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 Outcome Measures

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