Target-controlled Infusion Model for Cefepime

Onze Lieve Vrouw Hospital21 enrolled

Overview

For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Antimicrobial Treatment

Interventions

TCI groupOTHER

Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment * Patients within the weight range of 50 -120kg * Patients with calculated creatinine clearance within the range 15 to \> 90 ml/min, allocated to one of three groups as described above. * Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible. * Patient with an arterial catheter in place for other reason than the current study purpose Exclusion Criteria: * Patients displaying acute or chronic renal failure requiring renal replacement therapy * Pregnancy * Moribund patients * Known sensitivity or allergy to cefepime * Inclusion in another study involving antimicrobial treatment. * Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority. * Patient already previously included in the trial

Outcomes

Primary Outcomes

Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)

Time frame: During the first 5 days of cefepime therapy

Secondary Outcomes

Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria

Time frame: Evaluation during the first 5 days of cefepime therapy

Negativation of microbiological cultures

When applicable, evaluation of semi-quantitative culture of clinical samples (e.g. respiratory samples). This is not mandatory for study inclusion.

Time frame: Evaluation during the first 5 days of cefepime therapy

Percentage of patients with clinical cure

Clinical cure when all criteria are met: * Patient not deceased * WBC count between 4000/µL and 11000/µL OR decreased by 25% relative to peak value * CRP decrease of 50% relative to peak value * If respiratory infection: i) absence or decrease in sputa/tracheal secretions; ii) extubated and not re-intubated within 24h after cessation of cefepime (if relevant) * Body temperature between 35°C and 38°C

Time frame: At the end of the study (maximum 5 days after inclusion)

Data from ClinicalTrials.gov

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