Pharmacokinetics of Antibiotics in Bile Fluid of Patients with Cholangitis Undergoing External Biliary Drainage

The primary objective of this study is to evaluate the **pharmacokinetics** of antibiotics in the bile fluid of patients with external biliary drainage. This is clinically relevant as understanding the pharmacokinetics in this specific fluid can inform dosing strategies and improve therapeutic outcomes for patients with **cholangitis**, a condition characterized by inflammation of the bile duct system. The study aims to provide insights into how antibiotics are processed in the body when external biliary drainage is present, which is crucial for optimizing treatment regimens and ensuring effective management of the infection.

The clinical trial involves participants diagnosed with **cholangitis**, a condition characterized by inflammation of the bile duct system. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. The trial does not focus on a vulnerable population, and the selection criteria for participants have not been disclosed by the sponsor. The total number of participants involved in the trial has not been provided. Lifestyle considerations such as diet, physical activity, or habits have not been specified. The sponsor has not given information regarding key inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the **pharmacokinetics** of antibiotics in the bile fluid of patients with external biliary drainage, specifically targeting individuals diagnosed with **cholangitis**. This study is structured as a Phase 3 trial, with an estimated recruitment start date of June 10, 2024, and an anticipated completion by February 1, 2026. The trial will employ a randomized, double-blind, controlled design to ensure the reliability and validity of the results. Participants will be involved in the study for its entire duration unless specific conditions necessitate early termination, such as adverse reactions or non-compliance with the study protocol.

The sequence of study visits begins with an inclusion visit, where potential participants will undergo screening to confirm eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits, which are essential for monitoring the safety and efficacy of the treatment, as well as for collecting necessary data on the pharmacokinetics of the antibiotics. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data for analysis. The study is designed to ensure that all procedures are conducted in a manner that prioritizes participant safety and data integrity.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on June 10, 2024, with an estimated completion date of February 1, 2026. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The focus will be on evaluating the treatment's impact on the specified medical condition, utilizing appropriate scientific methodologies to ensure the reliability and validity of the results.