NCT06999161 Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
| NCT ID | NCT06999161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2025-05-05 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Augmented Renal Clearance (ARC), defined as a supraphysiological increase in renal function, is frequently observed in critically ill patients, particularly those with acute brain injury. ARC complicates the management of renally eliminated drugs, specifically beta-lactam antibiotics, by enhancing drug clearance and thereby increasing the risk of underdosing and therapeutic failure. Although pharmacological therapeutic drug monitoring (TDM) is recommended to optimize dosing, it remains limited by issues of accessibility, highlighting the need for alternative approaches to identify at-risk patients and adjust dosing based on renal function. Early identification of patients at risk for subtherapeutic beta-lactam plasma concentrations could enable timely dose adjustments. A combined assessment of renal function and beta-lactam TDM could enhance our understanding of the kinetics of both parameters. These data may support the development of predictive models capable of proposing individualized dosing regimens based on renal function. Optimizing beta-lactam plasma concentrations in this patient population could improve infection management and potentially enhance clinical outcomes.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years old) * Admitted to the intensive care unit for acute brain injury * Exhibiting Augmented Renal Clearance (ARC), defined by a urinary creatinine clearance (ClCrU) greater than 130 mL/min/1.73 m² on at least one measurement * Receiving Therapeutic Drug Monitoring (TDM)-guided treatment with one of the following beta-lactam antibiotics: amoxicillin/clavulanic acid, cefotaxime, piperacillin/tazobactam, cefepime, or meropenem * Affiliated with or benefiting from a health insurance scheme Exclusion Criteria: * Estimated life expectancy \<24 hours * Patients who have expressed opposition to study participation * Patients under legal protection (guardianship, curatorship, or court protection) * Patients currently in an exclusion period determined by participation in another study * Patients already enrolled in a study that precludes concurrent participation in an observational study
Frequently Asked Questions
Who can join the NCT06999161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06999161 currently recruiting?
Yes, NCT06999161 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier Universitaire de Nīmes to inquire about joining.
Where is the NCT06999161 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT06999161 clinical trial?
NCT06999161 is sponsored by Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 140 participants.