Target-controlled Infusion Model for Cefepime

Not Applicable

Completed

• Conditions: Antimicrobial Treatment
• Interventions: Other: TCI group

• Registration Number: NCT02688582
• Lead Sponsor: Onze Lieve Vrouw Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-06
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Study Start: 2016-03-01
• Primary Completion: 2018-03-01
• Status Verified: 2019-02
• Study Completion: 2019-02-28
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCI group	TCI group	Patients who receive cefepime based on TCI for a maximum of 5 days with a target concentration of cefepime of 16 mg/L.

Primary Outcome Measures

Name	Time	Method
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)	During the first 5 days of cefepime therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria	Evaluation during the first 5 days of cefepime therapy
Negativation of microbiological cultures	Evaluation during the first 5 days of cefepime therapy	When applicable, evaluation of semi-quantitative culture of clinical samples (e.g. respiratory samples). This is not mandatory for study inclusion.
Percentage of patients with clinical cure	At the end of the study (maximum 5 days after inclusion)	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