Pharmacokinetics of Ceftazidime-Avibactam in Bile Fluid – an in-vivo Study

Phase 2

• Conditions: A04; K83.0; Other bacterial intestinal infections; Cholangitis

• Registration Number: DRKS00023533
• Lead Sponsor: niversitätsklinikum Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerzmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Study Completion: 2022-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Male or female patients / 18 to 64 years of age / Patient requiring cholecystectomy because of cholecystitis or cholecystolithiasis or other elective abdominal surgery

Exclusion Criteria

Treatment with investigational drug within 28 days prior to start of study medication / Contra-indication for a perioperative antibiotic prophylaxis according to the standard in-house regimen (e.g. cholecystectomy with perforation of gallbladder) / Any medication considered relevant for proper performance of the study at the discretion of the investigator / Sepsis / Severe hepatitis or severe hepatic dysfunction / Renal impairment with need of renal replacement therapy / Pregnancy or lactation / Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator. Explicitly an icterus, cholestasis, cholangitis, cholecytitis, hepatitis, congested liver, allergies, Clostridioides-difficile infection, relevant concomitant medication (e.g. metformin, ursodeoxycholic acid, statins) must be considered / No written informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bile CAZ/AVI concentrations at 2h±1h (n=4), 4h±1h (n=4), and 8h±1h (n=4) after continuous intravenous infusion over 2 hours.

Secondary Outcome Measures

Name	Time	Method
Plasma CAZ/AVI concentrations at baseline and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7,h and 8h after CAZ/AVI infusion. Key pharmacokinetic parameters of CAZ/AVI in plasma and bile fluid.