PHARMACOKINETICS OF CEFEPIME AFTER INTRAPERITONEAL ADMINISTRATION VIA CYCLER-THERAPY IN APD PATIENTS WITHOUT PERITONITIS

Phase 1

• Conditions: CKD 5, Peritoneal Dialysis; Therapeutic area: Phenomena and Processes [G] - Chemical Phenomena [G02]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-509930-21-00
• Lead Sponsor: oe LGA Gesundheit Region Mitte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Males or females over the age of 18, APD regime has to be established for a minimum of 1 month, For short nighttime dwells patient need to use a glucose-based PDF (1,36% and/or 2.27%) and Icodextrin for the long daytime dwell, Preparedness and Compliance to the protocol, Signed informed consent

Exclusion Criteria

Any form of systemic infection, Any disease that might hinder proper study performance or puts the patient at risk, Severe hepatic impairment (Child-Pugh Class C), Severe hepatic impairment (Child-Pugh Class C), Pregnancy or woman of childbearing potential not minded to use appropriate contraception during the time of the study, Allergic or hypersensitive reactions against cephalosporins, Hemoglobin below 9 g/dl, BMI below 19 or above 35

Study & Design

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