Clinical Trials Directory

Trials / Completed

CompletedNCT04530045

Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients

Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study

Status
Completed
Phase
Study type
Observational
Enrollment
99 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes. Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity. For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care

Conditions

Interventions

TypeNameDescription
OTHERdosage of concentration of piperacillin and cefepimDosage of total plasma concentration of piperacillin and cefepim at different timepoints

Timeline

Start date
2018-05-02
Primary completion
2019-11-01
Completion
2019-11-02
First posted
2020-08-28
Last updated
2020-08-28

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04530045. Inclusion in this directory is not an endorsement.