Infectious DiseaseSPT BETALACTNCT05352997
Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
An observational study of Infectious Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital. The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients admitted to a critical care unit and treated for an infectious episode with beta-lactam, who received a Therapeutic Drug Monitoring. All patients older than 18 years recorded between 1/1st/2018 and 3/4th/2021 were included.
Who may be able to join
- Patient aged at least (≥) 18 years of age.
- Patient (or his representative for patients unable to give their consent) has given his free and informed consent and has signed the consent form.
- Patient affiliated to the health insurance scheme
- Patient hospitalized in one of the critical care services of Nimes' community hospital with at least one beta-lactam treatment
- Patient with at least one beta-lactam TDM during his stay
Who cannot join
- Patient who did not consent the use of his personal data
- Patients under maintenance of justice, tutelage or legal guardianship
- Patient previously included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.
The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.
Read more
Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.
The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.
Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?
- Conditions
- Infectious Disease
- Keywords
- beta-lactam, lCU
- Medical subject headings
- Communicable Diseases
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 |
|---|---|---|
| Group 1: on-target beta-lactams serum concentration | Patients with on-target beta-lactams serum concentration during 1st dosing | |
| Group 2: off-target beta-lactams serum concentration | Patients with off-target beta-lactams serum concentrations during 1st dosing | |
| Group 3: off-target beta-lactams plasma concentration: | Patients with high beta-lactams plasma concentrations during 1st dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify factors associated with adequate beta lactam plasma concentrations on the first sample
Determinants of adequate beta-lactams plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM
Measured: Day 7
Secondary outcomes (4)
To identify factors related with on-target beta-lactams plasma concentrations on the second sample
Risk factors of inadequate beta-lactam plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM.
Measured: Day 7
To identify factors related with on-target beta-lactams plasma concentrations on the second sample
Proportion of on target 2nd dosing after inadequate first dosing
Measured: Day 7
Impact of TDM
Mean number of TDM per patient with off-target first dosing and delay to achieve target plasma concentrations.
Measured: Day 7
To assess if beta-lactams and Aminoglycosides have the same elimination kinetic
Linkage between beta-lactams and aminoglycosides' trough concentrations for patients concurrently treated by both antibiotics.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseaseStudies 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
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ROGER, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352997
- Sponsor's protocol ID
- LOCAL/2021/HG-01
- Acronym
- SPT BETALACT
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gandega H, Poujol H, Mezzarobba M, Muller L, Boyer JC, Lefrant JY, Leguelinel G, Roger C. Determinants of beta-lactam PK/PD target attainment in critically ill patients: A single center retrospective study. J Crit Care. 2024 Oct;83:154828. doi: 10.1016/j.jcrc.2024.154828. Epub 2024 May 17.
PubMed 38759580
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Factors of Target Serum Concentrations Attainment From Beta-lactams Therapeutic Drug Monitoring in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05352997
- Acronym / sponsor ID
- SPT BETALACT / LOCAL/2021/HG-01
- Conditions
- Infectious Disease
- Keywords
- beta-lactam, lCU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Apr 2022 (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.
The population of these monocentric and retrospective study includes patients hospitalized in one of the critical care services of Nîmes' community hospital.
The objective is to determine the key factors that lead to satisfactory beta-lactams serum concentrations in critically ill patients.
Clinical and biological features, as well as risk scores are collected and recorded into an electronic Case Report Form.
The primary outcome is to show the main characteristics related to adequate beta-lactams serum concentrations in critically ill inpatients.
Secondary outcomes include the key factors related to inadequate beta-lactams serum concentrations in critically ill inpatients, Therapeutic Drug Monitoring (TDM) impact in the achievement of target beta-lactams serum concentration and the correlation between Aminoglycosides and Beta-lactams serum concentrations. Do both antibiotics have similar elimination kinetics ?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: on-target beta-lactams serum concentration | – | –Patients with on-target beta-lactams serum concentration during 1st dosing |
| Group 2: off-target beta-lactams serum concentration | – | –Patients with off-target beta-lactams serum concentrations during 1st dosing |
| Group 3: off-target beta-lactams plasma concentration: | – | –Patients with high beta-lactams plasma concentrations during 1st dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to a critical care unit and treated for an infectious episode with beta-lactam, who received a Therapeutic Drug Monitoring. All patients older than 18 years recorded between 1/1st/2018 and 3/4th/2021 were included.
Key inclusion criteria (5 listed)
- Patient aged at least (≥) 18 years of age.
- Patient (or his representative for patients unable to give their consent) has given his free and informed consent and has signed the consent form.
- Patient affiliated to the health insurance scheme
- Patient hospitalized in one of the critical care services of Nimes' community hospital with at least one beta-lactam treatment
- Patient with at least one beta-lactam TDM during his stay
Key exclusion criteria (3 listed)
- Patient who did not consent the use of his personal data
- Patients under maintenance of justice, tutelage or legal guardianship
- Patient previously included in the 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
To identify factors associated with adequate beta lactam plasma concentrations on the first sample
Time frame: Day 7
Determinants of adequate beta-lactams plasma concentrations using a univariate, then a multivariate analysis on patients 'characteristics at baseline and on the day of TDM
4 secondary outcomes
To identify factors related with on-target beta-lactams plasma concentrations on the second sample
Time frame: Day 7
To identify factors related with on-target beta-lactams plasma concentrations on the second sample
Time frame: Day 7
Impact of TDM
Time frame: Day 7
To assess if beta-lactams and Aminoglycosides have the same elimination kinetic
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 38759580Gandega H, Poujol H, Mezzarobba M, Muller L, Boyer JC, Lefrant JY, Leguelinel G, Roger C. Determinants of beta-lactam PK/PD target attainment in critically ill patients: A single center retrospective study. J Crit Care. 2024 Oct;83:154828. doi: 10.1016/j.jcrc.2024.154828. Epub 2024 May 17.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Claire ROGER, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Infectious Disease, 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 3 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify factors associated with adequate beta lactam plasma concentrations on the first sample (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352997, which also lists 1 linked publication.
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 4 Dec 2025.