Therapeutic Drug Monitoring of Anti-infectious Drugs in Intensive Care Unit
STP-ATB-REA
Evaluation of the Use of Therapeutic Drug Monitoring in the Management of Infections in Intensive Care Unit Patients.
1 other identifier
interventional
180
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedNovember 14, 2017
November 1, 2017
2.4 years
November 8, 2017
November 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
14 days
Secondary Outcomes (1)
efficacy of the treatment with the clinical response at the end of treatment
14 days
Study Arms (1)
blood sample group
EXPERIMENTALAdult patient hospitalized in intensive care unit and treated for infection.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age \<18
- Pregnant woman
- Patient allergic to beta-lactams
- No written informed consent by the patient or his/her (legal) representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Zalta 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.
PMID: 40192838DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle DESALBRES
Assistance Publique Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2017
First Posted
November 13, 2017
Study Start
January 2, 2018
Primary Completion
June 2, 2020
Study Completion
October 31, 2020
Last Updated
November 14, 2017
Record last verified: 2017-11