Clinical impact of pharmacokinetic monitoring of antibiotics in critically ill patients

Phase 1

• Conditions: Critical Patients admitted to the ICU; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-504480-17-00
• Lead Sponsor: Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Patients who are candidates for study entry must meet the following criteria (detailed in sections 5.1 Study Type and Design): - Age = 18 years. - Patients admitted to the Intensive Care Unit (ICU) who start treatment with the antibiotics under study and who meet the criteria for inclusion in the intervention or control group (detailed in sections 5.1 Study design). - Intervention group: initiation of treatment during the 48 hours prior to the plasma concentration determination (day and time set weekly). - Control group: start of treatment from the weekly time at which the plasma concentration of the intervention group is determined, until the same number of patients as the intervention group is reached that same week.

Exclusion Criteria

Patients with a duration of antibiotic treatment < 72 hours, have an ICU stay < 48 hours or do not meet the inclusion criteria are excluded.

Study & Design

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