Infection, BacterialSTP-ATB-REANCT03339869
Therapeutic Drug Monitoring of Anti-infectious Drugs in Intensive Care Unit
A study testing Blood sample in people with Infection, Bacterial, run by Assistance Publique Hopitaux De Marseille.
Trial summary
This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2018to 31 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient (age> 18 years)
- Patient hospitalized in intensive care for a duration greater than 7 days, treated with cefotaxime, ceftazidime, cefepime, piperacillin or meropenem according to a standardized dosing regimen.
Who cannot join
- Age <18
- Pregnant woman
- Patient allergic to beta-lactams
- No written informed consent by the patient or his/her (legal) representative
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Use of Therapeutic Drug Monitoring in the Management of Infections in Intensive Care Unit Patients.
This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.
Read the detailed description
Antibiotics, and especially beta-lactams, are among the most used drugs in the world. The good use of antibiotics and the prevention of selection of resistant strains has been a public health priority for many years. In this context, it is essential to obtain effective antibiotic concentrations at the site of infection. In order to obtain effective concentrations, ceftazidime, cefepime, cefotaxime, piperacillin and meropenem are administered in this population by continuous infusion at high dose. Although beta-lactams are mostly well tolerated, they can cause adverse effects such as severe neurological toxicities.
The critically ill patient has physiological alterations that can significantly alter the pharmacokinetics of drugs. Several studies have clearly shown that the pharmacokinetics of beta-lactams in the critically ill patient is different from those of other patients. Depending on the clinical context and the co-morbidities of the patient, sub-therapeutic or potentially toxic concentrations can be observed for the same dosage. The risk of ineffective treatment and the development of resistance remains, despite the high doses administered. In addition, this pharmacokinetic variability may be responsible for the observation of toxic concentrations and the occurrence of adverse effects in this population.
Following these arguments, therapeutic drug monitoring (TDM) of beta-lactams accompanied by personalized dosage adjustment appears to be an essential tool to optimize the management of critically ill patients. Although strongly recommended, the TDM of beta-lactams in the critically ill patient accompanied by a dosage adjustment is not currently performed systematically in all patients.
The objective of this study is to evaluate the impact of the use of a systematic therapeutic drug monitoring of beta-lactams in the critically ill treated with cefotaxime, ceftazidime, cefepime, meropenem or piperacillin, in terms of efficacy and prevention of neurotoxicity.
- Conditions
- Infection, Bacterial
- Being tested
- Blood sample
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
The blood samples will be taken from the patient's bed and then sent to the clinical pharmacology laboratory of Prof. Blin (DRC, Bat F, Timone Hospital).
| Study group | Role | What they receive |
|---|---|---|
| blood sample group | Experimental | Adult patient hospitalized in intensive care unit and treated for infection. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of betalactamins concentrations
Target concentrations are determined from the PK/PD target defined for betalactamins in the intensive care patient, ie a steady-state concentration 100% of the time at 4-5xMIC.
Measured: 14 days
Secondary outcomes (1)
efficacy of the treatment with the clinical response at the end of treatment
Evaluate the efficacy of the treatment with the clinical response at the end of treatment and/or J14 according to the criteria of "resolution / improvement / failure" according to De Waele et al. (Intensive Care Medicine 2014 Sep; 40 (9): 1340-51)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start2 Jan 2018 (estimated)
- Primary completion2 Jun 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patient hospitalized in intensive care unit
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339869
- Sponsor's protocol ID
- 2017-05
- Acronym
- STP-ATB-REA
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guilhaumou R, Foinet E, Duclos G, Alkassab W, Deschamps A, Jouve E, Lipman J, Velly L, Leone M. Implementation of beta-lactam Therapeutic Drug Monitoring in clinical practice: a prospective, comparative, interventional study in intensive care unit patients. Anaesth Crit Care Pain Med. 2026 Oct 5:101929. doi: 10.1016/j.accpm.2026.101929. Online ahead of print.
PubMed 42833603Zalta A, Trebuchon A, Daquin G, Velly L, Leone M, Blin O, Lagarde S, Guilhaumou R. Neural correlates of beta-lactam exposure in intensive care unit patients: an observational, prospective cohort study. J Neurol. 2025 Apr 7;272(5):320. doi: 10.1007/s00415-025-13067-3.
PubMed 40192838
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Therapeutic Drug Monitoring in the Management of Infections in Intensive Care Unit Patients.
- ClinicalTrials.gov ID
- NCT03339869
- Acronym / sponsor ID
- STP-ATB-REA / 2017-05
- Conditions
- Infection, Bacterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Jan 2018 (estimated)
- Primary completion
- 2 Jun 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 13 Nov 2017 (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.
This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.
Detailed description
Antibiotics, and especially beta-lactams, are among the most used drugs in the world. The good use of antibiotics and the prevention of selection of resistant strains has been a public health priority for many years. In this context, it is essential to obtain effective antibiotic concentrations at the site of infection. In order to obtain effective concentrations, ceftazidime, cefepime, cefotaxime, piperacillin and meropenem are administered in this population by continuous infusion at high dose. Although beta-lactams are mostly well tolerated, they can cause adverse effects such as severe neurological toxicities.
The critically ill patient has physiological alterations that can significantly alter the pharmacokinetics of drugs. Several studies have clearly shown that the pharmacokinetics of beta-lactams in the critically ill patient is different from those of other patients. Depending on the clinical context and the co-morbidities of the patient, sub-therapeutic or potentially toxic concentrations can be observed for the same dosage. The risk of ineffective treatment and the development of resistance remains, despite the high doses administered. In addition, this pharmacokinetic variability may be responsible for the observation of toxic concentrations and the occurrence of adverse effects in this population.
Following these arguments, therapeutic drug monitoring (TDM) of beta-lactams accompanied by personalized dosage adjustment appears to be an essential tool to optimize the management of critically ill patients. Although strongly recommended, the TDM of beta-lactams in the critically ill patient accompanied by a dosage adjustment is not currently performed systematically in all patients.
The objective of this study is to evaluate the impact of the use of a systematic therapeutic drug monitoring of beta-lactams in the critically ill treated with cefotaxime, ceftazidime, cefepime, meropenem or piperacillin, in terms of efficacy and prevention of neurotoxicity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patient hospitalized in intensive care unit
| Arm | Type | Receives |
|---|---|---|
| blood sample group | Experimental | Other: Blood sampleAdult patient hospitalized in intensive care unit and treated for infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient (age> 18 years)
- Patient hospitalized in intensive care for a duration greater than 7 days, treated with cefotaxime, ceftazidime, cefepime, piperacillin or meropenem according to a standardized dosing regimen.
Key exclusion criteria (4 listed)
- Age <18
- Pregnant woman
- Patient allergic to beta-lactams
- No written informed consent by the patient or his/her (legal) representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleThe blood samples will be taken from the patient's bed and then sent to the clinical pharmacology laboratory of Prof. Blin (DRC, Bat F, Timone Hospital). | Other | blood sample group |
Primary outcome
dosage of betalactamins concentrations
Time frame: 14 days
Target concentrations are determined from the PK/PD target defined for betalactamins in the intensive care patient, ie a steady-state concentration 100% of the time at 4-5xMIC.
1 secondary outcome
efficacy of the treatment with the clinical response at the end of treatment
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 42833603Guilhaumou R, Foinet E, Duclos G, Alkassab W, Deschamps A, Jouve E, Lipman J, Velly L, Leone M. Implementation of beta-lactam Therapeutic Drug Monitoring in clinical practice: a prospective, comparative, interventional study in intensive care unit patients. Anaesth Crit Care Pain Med. 2026 Oct 5:101929. doi: 10.1016/j.accpm.2026.101929. Online ahead of print.
- Derived from this study: PubMed 40192838Zalta A, Trebuchon A, Daquin G, Velly L, Leone M, Blin O, Lagarde S, Guilhaumou R. Neural correlates of beta-lactam exposure in intensive care unit patients: an observational, prospective cohort study. J Neurol. 2025 Apr 7;272(5):320. doi: 10.1007/s00415-025-13067-3.
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Infection, Bacterial, run by Assistance Publique Hopitaux De Marseille.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain GUILHAUMOU (491.38.96.56/75.65 ext. +33, Romain.GUILHAUMOU@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosage of betalactamins concentrations (time frame: 14 days). 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 NCT03339869, which also lists 2 linked publications.
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 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.