Monitoring beta-lactam antibiotics and kidney clearance in ICU patients with acute brain injury
Official title: Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
Run by Centre Hospitalier Universitaire de Nīmes · NCT06999161 · Data updated 2026-11-12
This project tries to see if checking kidney clearance together with blood drug levels can quickly identify ICU patients with acute brain injury who need higher doses of beta-lactam antibiotics.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Status | Recruiting |
| Started | May 5, 2025 |
| Main results expected | November 2025 |
| Study ends | December 2025 |
| Registry record updated | May 31, 2025 |
| Trial ID | NCT06999161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) admitted to the ICU for acute brain injury who show augmented renal clearance (>130 mL/min/1.73 m²) and are receiving one of the listed beta-lactam antibiotics with TDM.
✕Probably not a fit
Patients with life expectancy under 24 hours, those under legal protection, those who decline participation, or patients not receiving the specified beta-lactams or without ARC are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults admitted to the intensive care unit for acute brain injury who receive TDM-guided treatment with specified beta-lactam antibiotics. Investigators will record urinary creatinine clearance to identify augmented renal clearance (ClCrU >130 mL/min/1.73 m²) and pair those measurements with beta-lactam plasma concentrations. No experimental interventions are given; data are used to describe pharmacokinetics and the relationship between renal clearance and drug levels. The goal is to produce datasets that could support predictive models for individualized dosing decisions.
Why it matters
Potential benefit: If successful, this could help clinicians spot patients whose kidneys clear beta-lactams too quickly so doses can be adjusted to avoid underdosing and treatment failure.
How similar studies have gone: Therapeutic drug monitoring has been shown to improve beta-lactam target attainment in critically ill patients, but combining systematic renal clearance measurements with TDM to build predictive models specifically in acute brain injury is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France Recruiting
Study contacts
- Study coordinator: Claire ROGER, MD, pHD
- Email: claire.roger@chu-nimes.fr
- Phone: +33 466683331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.