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Completed

NCT Number: NCT02688582

Target-controlled Infusion Model for Cefepime

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.

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Key information

Conditions

Antimicrobial Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCI group

Other

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

Primary outcomes

  1. 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

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

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

  2. Negativation of microbiological cultures

    Time frame: 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.

  3. Percentage of patients with clinical cure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Collaborators

  • University Ghent
  • University Medical Center Groningen

Registry information

Official study title

A Study to Evaluate the Predictive Performance of a Target-controlled Infusion Model for the Administration of Cefepime to Intensive Care Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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