Critical IllnessBETALACT-ARCNCT06999161
Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
An observational study of Critical Illness and Brain Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Brain Injuries
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population studied included patients admitted to the intensive care unit with acute brain injury (of traumatic, vascular, infectious or immunological origin), presenting a profile of HCR and receiving antibiotic treatment with betalactam
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Claire ROGER, MD, PhD
Claire ROGER, MD, PhD
About this study
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.
- Conditions
- Critical Illness, Brain Injuries
- Keywords
- Beta-Lactams, Renal Clearance, Therapeutic Drug Monitoring
- Medical subject headings
- Critical Illness, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BETALACTAM Treated Patients | Adult patients (≥18 years) admitted to intensive care for acute brain injury, presenting with an infectious episode, documented augmented renal clearance (as assessed by urinary creatinine clearance), and receiving treatment with beta-lactam antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma betalactam underdosing
Development of a predictive model for plasma beta-lactam underdosing in critically ill patients with acute brain injury and renal hyperclearance, receiving beta-lactam therapy for an ongoing infectious episode.
Plasma beta-lactam concentrations will be measured 24 hours after initiation of antibiotic therapy, and subsequently every 48 hours, or in cases of underdosing, overdosing, antibiotic switch, or significant changes in renal function.
Measured: 24 hours after the start of antibiotic therapy, and repeated every 48 hours or in the event of underdosing, overdosing, change of molecule or significant variation in renal function, assessed until the antibiotic therapy is stopped, for up to 14 days
Secondary outcomes (5)
Evolution of Augmented Renal Clearance
Assessment of urinary creatinine clearance based on urine collection (8, 12, or 24-hour collection depending on center practices).
Measured: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Evolution of plasma Beta-lactam Concentration
Monitoring of total plasma beta-lactam concentrations obtained through Therapeutic Drug Monitoring during the intensive care stay
Measured: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Relationship Between Plasma Underdosing Intensity and Level of Augmented Renal Clearance (ARC)
Characterization of the intensity of plasma beta-lactam underdosing for each antibiotic molecule relative to the degree of ARC.
Measured: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Beta-lactam Dosing According to Augmented Renal Clearance Level.
Development of a dosing nomogram for beta-lactam antibiotics tailored to the degree of ARC.
Measured: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Clinical outcome
Assessment of clinical outcomes based on rates of clinical success and failure.
- Clinical success is defined as the resolution of infectious symptoms present at the initiation of antibiotic therapy, allowing discontinuation of antibiotics at the end of the planned treatment duration.
- Clinical failure is defined as the persistence or worsening of initial symptoms, the occurrence of superinfection (infection with newly identified pathogens), or recurrence (a new infectious episode with the same pathogen).
Measured: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start5 May 2025
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999161
- Sponsor's protocol ID
- LOCAL/2025/CR-01
- Acronym
- BETALACT-ARC
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Beta-lactams and Renal Hyperclearance in Patients Admitted to Intensive Care for Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06999161
- Acronym / sponsor ID
- BETALACT-ARC / LOCAL/2025/CR-01
- Conditions
- Critical Illness, Brain Injuries
- Keywords
- Beta-Lactams, Renal Clearance, Therapeutic Drug Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BETALACTAM Treated Patients | – | –Adult patients (≥18 years) admitted to intensive care for acute brain injury, presenting with an infectious episode, documented augmented renal clearance (as assessed by urinary creatinine clearance), and receiving treatment with beta-lactam antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied included patients admitted to the intensive care unit with acute brain injury (of traumatic, vascular, infectious or immunological origin), presenting a profile of HCR and receiving antibiotic treatment with betalactam
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma betalactam underdosing
Time frame: 24 hours after the start of antibiotic therapy, and repeated every 48 hours or in the event of underdosing, overdosing, change of molecule or significant variation in renal function, assessed until the antibiotic therapy is stopped, for up to 14 days
Development of a predictive model for plasma beta-lactam underdosing in critically ill patients with acute brain injury and renal hyperclearance, receiving beta-lactam therapy for an ongoing infectious episode. Plasma beta-lactam concentrations will be measured 24 hours after initiation of antibiotic therapy, and subsequently every 48 hours, or in cases of underdosing, overdosing, antibiotic switch, or significant changes in renal function.
5 secondary outcomes
Evolution of Augmented Renal Clearance
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Evolution of plasma Beta-lactam Concentration
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Relationship Between Plasma Underdosing Intensity and Level of Augmented Renal Clearance (ARC)
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Beta-lactam Dosing According to Augmented Renal Clearance Level.
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Clinical outcome
Time frame: From date of inclusion until the date of discharge from intensive care, assessed up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Brain Injuries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire ROGER, MD, pHD (+33 466683331, claire.roger@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma betalactam underdosing (time frame: 24 hours after the start of antibiotic therapy, and repeated every 48 hours or in the event of underdosing, overdosing, change of molecule or significant variation in renal function, assessed until the antibiotic therapy is stopped, for up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.