Pharmacokinetics Clinical Trial
Official title:
A Pharmacokinetic Study to Evaluate the Use of a Novel Clinical Decision Support Tool, Lyv, in Achieving AUC24/MIC > 400 in Pediatric Patients on Vancomycin
Verified date | April 2024 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | October 2024 |
Est. primary completion date | April 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - Hospitalized infants and children from postmenstrual age of 38 weeks to age 19 years Requiring IV vancomycin, regardless of indication - Parent or legally authorized representative is willing to provide permission and sign the informed consent document; subjects assent, when appropriate - Hospitalized neonates, infants, children, adolescents who require, but have not been initiated on intravenous vancomycin therapy Exclusion Criteria: - Patients who had received vancomycin during previous 2 weeks - Patients with end-stage renal disease, receiving hemodialysis or receiving continuous renal replacement therapy - On oral or intraperitoneal vancomycin - Receiving extracorporeal therapy, including extracorporeal membrane oxygenation, continuous renal replacement therapy, and extracorporeal liver support - Will only receive a single dose of vancomycin - Known to be pregnant - Is brain dead or has suspected brain death |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Center for Translational Medicine at the School of Pharmacy, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Gerber JS, Coffin SE, Smathers SA, Zaoutis TE. Trends in the incidence of methicillin-resistant Staphylococcus aureus infection in children's hospitals in the United States. Clin Infect Dis. 2009 Jul 1;49(1):65-71. doi: 10.1086/599348. — View Citation
Giachetto GA, Telechea HM, Speranza N, Oyarzun M, Nanni L, Menchaca A. Vancomycin pharmacokinetic-pharmacodynamic parameters to optimize dosage administration in critically ill children. Pediatr Crit Care Med. 2011 Nov;12(6):e250-4. doi: 10.1097/PCC.0b013e3181fe4047. — View Citation
Gous AG, Dance MD, Lipman J, Luyt DK, Mathivha R, Scribante J. Changes in vancomycin pharmacokinetics in critically ill infants. Anaesth Intensive Care. 1995 Dec;23(6):678-82. doi: 10.1177/0310057X9502300603. — View Citation
Heil EL, Claeys KC, Mynatt RP, Hopkins TL, Brade K, Watt I, Rybak MJ, Pogue JM. Making the change to area under the curve-based vancomycin dosing. Am J Health Syst Pharm. 2018 Dec 15;75(24):1986-1995. doi: 10.2146/ajhp180034. Epub 2018 Oct 17. No abstract available. — View Citation
Hughes DM, Goswami S, Keizer RJ, Hughes MA, Faldasz JD. Bayesian clinical decision support-guided versus clinician-guided vancomycin dosing in attainment of targeted pharmacokinetic parameters in a paediatric population. J Antimicrob Chemother. 2020 Feb 1;75(2):434-437. doi: 10.1093/jac/dkz444. — View Citation
Iwamoto M, Mu Y, Lynfield R, Bulens SN, Nadle J, Aragon D, Petit S, Ray SM, Harrison LH, Dumyati G, Townes JM, Schaffner W, Gorwitz RJ, Lessa FC. Trends in invasive methicillin-resistant Staphylococcus aureus infections. Pediatrics. 2013 Oct;132(4):e817-24. doi: 10.1542/peds.2013-1112. Epub 2013 Sep 23. — View Citation
Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL; AWARE Investigators. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med. 2017 Jan 5;376(1):11-20. doi: 10.1056/NEJMoa1611391. Epub 2016 Nov 18. — View Citation
Le J, Bradley JS, Murray W, Romanowski GL, Tran TT, Nguyen N, Cho S, Natale S, Bui I, Tran TM, Capparelli EV. Improved vancomycin dosing in children using area under the curve exposure. Pediatr Infect Dis J. 2013 Apr;32(4):e155-63. doi: 10.1097/INF.0b013e318286378e. — View Citation
Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children: executive summary. Clin Infect Dis. 2011 Feb 1;52(3):285-92. doi: 10.1093/cid/cir034. — View Citation
Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004;43(13):925-42. doi: 10.2165/00003088-200443130-00005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The number of dose changes before getting to the therapeutic dose, defined as the dose achieving AUC24/MIC > 400 | Each vancomycin dose, vancomycin level, number of dose changes, and percent difference from goal AUC24/MIC will be documented and assessed. Dose changes will be compared to historical controls. | From start to end of antibiotic therapy, or a max of 7 days | |
Primary | AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method | Vancomycin level will be drawn after first dose of antibiotic. The level will be entered into the CDS tool and AUC24/MIC target attainment will be generated. If the level is not in range, the CDS tool will generate a new dose for future doses. | 2-6 hours post first dose | |
Secondary | To characterize vancomycin pharmacokinetics and evaluate the factors that affect variability in achievement of an AUC24/MIC > 400 in pediatric patients | Factors such as weight, height, serum creatinine, fluid status, vancomycin dose, and vancomycin level will be documented. These factors will be compared to those in the historical controls. | From start to end of antibiotic therapy, or a max of 7 days | |
Secondary | To evaluate the incidence of nephrotoxicity for dosing vancomycin using the decision support tool compared to dosing using the current hospital method | Evaluate creatinine levels prior to starting, during, and after vancomycin therapy. Will also document concomitant medications, fluid balance, and illness and compare to historical controls.
Using creatinine levels, will assess AKI by KDIGO AKI definition. |
From start to end of antibiotic therapy, or a max of 7 days | |
Secondary | To evaluate the accuracy of the clinical decision support system in predicting the AUC24/MIC | Vancomycin levels will be drawn at random times throughout antibiotic therapy and will be entered into CDS tool and target attainment will be generated. These measurements will be documented, as well as a percentage from target, if target is not obtained | From start to end of antibiotic therapy, or a max of 7 days |
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