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

Sepsis Clinical Trial

— DOSATB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530045
• Other study ID #: PSS2018/DOSATB-NOVY/YB
• Status: Completed
• Start date: May 2, 2018
• Est. completion date: November 2, 2019

Study information

• Verified date: August 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 2, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Toxicity
• Critical Illness
• Sepsis
• Septic Shock

Intervention

Other:
• dosage of concentration of piperacillin and cefepim
Dosage of total plasma concentration of piperacillin and cefepim at different timepoints

Locations

Country	Name	City	State
France	Central Hospital	Vandoeuvre les Nancy
France	Emmanuel NOVY	Vandoeuvre Les Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours	PK/PD target "exposure" take into account only the the lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria; Consequently : for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is above 32 mg/l; for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is above 4 mg/l	Day 1
Secondary	factors associated with target attainment at day 1	effect of age on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	factors associated with target attainment at day 1	effect of renal clearance on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	factors associated with target attainment at day 1	effect of presence of septic shock on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	factors associated with dose changing	effect of presence of septic shock on number of dose changing after analyse of antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	factors associated with dose changing	effect of renal clearance on number of dose changing after analyse of antibiotic concentration	Statistical analysis after 2 years of inclusion