An interventional study of TCI group in Antimicrobial Treatment, sponsored by Onze Lieve Vrouw Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Onze Lieve Vrouw Hospital · Not applicable, Interventional, and Treatment
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.
Onze Lieve Vrouw Hospital is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)
Time frame: During the first 5 days of cefepime therapy
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)
No study locations are listed for this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Onze Lieve Vrouw Hospital