Target-controlled Infusion Model for Cefepime

NCT02688582 | Completed

• 1 other identifier: 2016/005
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antimicrobial Treatment

Keywords

Target Controlled Infusion; Pharmacokinetics; Cefepime; critically ill patients

Outcome Measures

Primary Outcomes (1)

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

  During the first 5 days of cefepime therapy

Secondary Outcomes (3)

• 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

• Percentage of patients with clinical cure

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

Study Arms (1)

TCI group

EXPERIMENTAL

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

Other: TCI group

Interventions

TCI group OTHER

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

TCI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient with an arterial catheter in place for other reason than the current study purpose

You may not qualify if:

• Patients displaying acute or chronic renal failure requiring renal replacement therapy
• Pregnancy
• Moribund patients
• Known sensitivity or allergy to cefepime
• Patient already previously included in the trial

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead
• University Ghent: collaborator
• University Medical Center Groningen: collaborator

Related Publications (1)

• Jonckheere S, De Neve N, Verbeke J, De Decker K, Brandt I, Boel A, Van Bocxlaer J, Struys MMRF, Colin PJ. Target-Controlled Infusion of Cefepime in Critically Ill Patients. Antimicrob Agents Chemother. 2019 Dec 20;64(1):e01552-19. doi: 10.1128/AAC.01552-19. Print 2019 Dec 20.

  PMID: 31685467 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2016
• First Posted: February 23, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: February 28, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02