Pharmacokinetics Clinical Trial
Official title:
Association of Cefepime Trough Levels With Clinical Efficacy and Neurotoxicity in Patients With Febrile Neutropenia
Verified date | April 2021 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this prospective monocenter observational study, the objective was to determine a safe and effective therapeutic window for cefepime in patients with neutropenic fever.
Status | Active, not recruiting |
Enrollment | 98 |
Est. completion date | May 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - admitted to the hemato-oncology ward - treated with cefepime for neutropenic fever - written informed consent Exclusion Criteria: - younger than 18 years old |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Aitken SL, Altshuler J, Guervil DJ, Hirsch EB, Ostrosky-Zeichner LL, Ericsson CD, Tam VH. Cefepime free minimum concentration to minimum inhibitory concentration (fCmin/MIC) ratio predicts clinical failure in patients with Gram-negative bacterial pneumonia. Int J Antimicrob Agents. 2015 May;45(5):541-4. doi: 10.1016/j.ijantimicag.2014.12.018. Epub 2015 Jan 19. — View Citation
Huwyler T, Lenggenhager L, Abbas M, Ing Lorenzini K, Hughes S, Huttner B, Karmime A, Uçkay I, von Dach E, Lescuyer P, Harbarth S, Huttner A. Cefepime plasma concentrations and clinical toxicity: a retrospective cohort study. Clin Microbiol Infect. 2017 Jul;23(7):454-459. doi: 10.1016/j.cmi.2017.01.005. Epub 2017 Jan 19. — View Citation
Lamoth F, Buclin T, Pascual A, Vora S, Bolay S, Decosterd LA, Calandra T, Marchetti O. High cefepime plasma concentrations and neurological toxicity in febrile neutropenic patients with mild impairment of renal function. Antimicrob Agents Chemother. 2010 Oct;54(10):4360-7. doi: 10.1128/AAC.01595-08. Epub 2010 Jul 12. — View Citation
Marsh E, Verhoven SM, Groszek JJ, Fissell WH, An G, Patel P, Creech B, Shotwell M. Beta-lactam carryover in arterial and central venous catheters is negligible. Clin Chim Acta. 2018 Nov;486:265-268. doi: 10.1016/j.cca.2018.08.008. Epub 2018 Aug 15. — View Citation
Rhodes NJ, Kuti JL, Nicolau DP, Neely MN, Nicasio AM, Scheetz MH. An exploratory analysis of the ability of a cefepime trough concentration greater than 22 mg/L to predict neurotoxicity. J Infect Chemother. 2016 Feb;22(2):78-83. doi: 10.1016/j.jiac.2015.10.009. Epub 2015 Dec 17. — View Citation
Rhodes NJ, Kuti JL, Nicolau DP, Van Wart S, Nicasio AM, Liu J, Lee BJ, Neely MN, Scheetz MH. Defining Clinical Exposures of Cefepime for Gram-Negative Bloodstream Infections That Are Associated with Improved Survival. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1401-10. doi: 10.1128/AAC.01956-15. — View Citation
Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, Kaukonen KM, Koulenti D, Martin C, Montravers P, Rello J, Rhodes A, Starr T, Wallis SC, Lipman J; DALI Study. DALI: defining antibiotic levels in intensive care unit patients: are current ß-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014 Apr;58(8):1072-83. doi: 10.1093/cid/ciu027. Epub 2014 Jan 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic failure | hemoculture positive for Gram negative bacteria during cefepime therapy | From Day 2 before until Day 2 day after day of sampling | |
Primary | Neurotoxicity: cognitive disturbance, confusion, depressed level of consciousness, encephalopathy, hallucinations, movements involuntary, seizure | Percent of patients and trough levels associated with one of following symptoms during cefepime therapy: cognitive disturbance, confusion, depressed level of consciousness, encephalopathy, hallucinations, movements involuntary, seizure | From Day 2 before until Day 2 day after day of sampling | |
Primary | Carryover cefepime in samples via central venous catheter | Difference between cefepime concentration in samples obtained via central venous catheter vs. samples obtained via peripheral venipuncture | From Day 2 before until Day 2 day after day of sampling | |
Secondary | Fever | Presence of fever per day of treatment, defined as T° above 38°C on two occasions (min. 1h apart) or above 38.3°C on one occasion | From Day 2 before until Day 2 day after day of sampling | |
Secondary | Clinical condition | Evolution in clinical condition compared to the previous day as evaluated by the treating physician, per day of treatment | From Day 2 before until Day 2 day after day of sampling |
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