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

NCT ID: NCT04530045

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2019-11-02

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

critically ill patients

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

dosage of concentration of piperacillin and cefepim

Intervention Type: OTHER

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

Interventions

dosage of concentration of piperacillin and cefepim

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel NOVY

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

Emmanuel NOVY

Vandœuvre-lès-Nancy, Lorraine, France

Central Hospital

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

PSS2018/DOSATB-NOVY/YB

Identifier Type: -

Identifier Source: org_study_id