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| Name | Class |
|---|---|
| University Ghent | OTHER |
| University Medical Center Groningen | OTHER |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCI group | Other | Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L) | During the first 5 days of cefepime therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | When applicable, evaluation of semi-quantitative culture of clinical samples (e.g. respiratory samples). This is not mandatory for study inclusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31685467 | Derived | 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. |
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| Evaluation during the first 5 days of cefepime therapy |
| Percentage of patients with clinical cure | Clinical cure when all criteria are met:
| At the end of the study (maximum 5 days after inclusion) |