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

NCT04530045 | Completed

• 1 other identifier: PSS2018/DOSATB-NOVY/YB
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 2

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

Conditions

Critical Illness; Antibiotic Toxicity; Sepsis; Septic Shock

Keywords

therapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

• to determine the percentage of patients who met the PK/PD targets at 24 hours

  PK/PD target was defined as follows: Concentration of piperacillin or cefepim between a lower and a upper limit: * The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria * The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively Consequently : * for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l * for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l

  Day 1

Secondary Outcomes (6)

• to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours

  Day 1

• factors associated with target attainment at day 1

  Statistical analysis after 2 years of inclusion

• factors associated with target attainment at day 1

  Statistical analysis after 2 years of inclusion

• factors associated with target attainment at day 1

  Statistical analysis after 2 years of inclusion

• factors associated with dose changing

  Statistical analysis after 2 years of inclusion

Study Arms (1)

critically ill patients

Critically ill patients receiving continuous infusion of piperacillin/tazbactam or cefepim and dosage of plasma concentration of the B lactam administered

Other: dosage of concentration of piperacillin and cefepim

Interventions

dosage of concentration of piperacillin and cefepim OTHER

Dosage of total plasma concentration of piperacillin and cefepim at different timepoints

critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

Emmanuel NOVY

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Central Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Shock, Septic

Interventions

Cefepime

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emmanuel NOVY

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: May 2, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 2, 2019
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)