Clinical trial NCT04530045: Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients
Official title: Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Antibiotic Toxicity
Sepsis
Septic Shock
Keywords: therapeutic drug monitoring
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the surgical intensive care unit whatever the reason of admission and who received piperacilin or cefepim with a TDM for sepsis or septic shock during their stay.

Brief 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


Eligibility criteria: Inclusion Criteria:

* Minimun age limits 18 years
* Critically ill patient receiving piperacillin or cefepim administered continuously

Exclusion Criteria:

* Beta lactam allergy
* Pregnancy
* Age less than 18 years

Primary outcomes:
measure: to determine the percentage of patients who met the PK/PD targets at 24 hours
timeFrame: Day 1
Secondary outcomes:
measure: to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours
timeFrame: Day 1
measure: factors associated with target attainment at day 1
timeFrame: Statistical analysis after 2 years of inclusion
measure: factors associated with target attainment at day 1
timeFrame: Statistical analysis after 2 years of inclusion
measure: factors associated with target attainment at day 1
timeFrame: Statistical analysis after 2 years of inclusion
measure: factors associated with dose changing
timeFrame: Statistical analysis after 2 years of inclusion
measure: factors associated with dose changing
timeFrame: Statistical analysis after 2 years of inclusion
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Emmanuel NOVY
state: Lorraine
city: Vandoeuvre les Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Emmanuel NOVY
role: PRINCIPAL_INVESTIGATOR
References: