PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock

Phase 3CompletedNCT02820987

Centre Hospitalier Universitaire de Besancon119 enrolled

Overview

This study evaluates PK/PD of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

Beta Lactams are the keystones of shock septic treatment. Early phase of septic shock is a period of disturbed pharmacokinetics, with augmented renal clearance and distribution volume of hydrophilic drugs as Beta Lactams. Consequently, early phase of septic shock is a period at risk of underdosing Beta Lactam, which could increase the risk of clinical failure an mortality. Data are available concerning underdosing of MEROPENEM, PIPERACILLIN-TAZOBACTAM and CEFEPIME, when administered in bolus. No data exist concerning the achievement of a target of 100% of the whole interval above 4 time the superior breakpoint of Pseudomonas Aeruginosa according to EUCAST (European Committee on Antimicrobial Susceptibility Testing), during the 48 first hours of treatment of septic shock, when Beta Lactam are administered in extended infusion.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Septic Shock

Interventions

MEROPENEMDRUG

Administration of MEROPENEM according to a protocol of extended infusion defining dose and duration of infusion.

PIPERACILLIN-TAZOBACTAMDRUG

Administration of PIPERACILLIN-TAZOBACTAM according to a protocol of continuous infusion defining dose and duration of infusion.

CEFEPIMEDRUG

Administration of CEFEPIME according to a protocol of continuous infusion defining dose and duration of infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Septic shock * Meropenem, piperacillin-tazobactam or cefepime started after enrollment Exclusion Criteria: * Pregnancy * Central nervous system infection * Burns

Locations (1)

Chu Besancon

Besançon, France

Outcomes

Primary Outcomes

Proportion of patients achieving the PK/PD target

Proportion of patients achieving the target of 100% of 48 first hours of treatment above 4 time the upper critical breakpoint for Pseudomonas Aeruginosa

Time frame: First 48 hours

Secondary Outcomes

All cause mortality

Time frame: 28th day

Data from ClinicalTrials.gov

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