Gram-Positive Bacterial InfectionsNCT04911270
Clinical Decision Support Tool for Vancomycin Dosing in Children
A study testing Computer Decision Support Tool Intervention Group in people with Gram-Positive Bacterial Infections and Vancomycin, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gram-Positive Bacterial Infections, Vancomycin, Pharmacokinetics
- What is being tested?
- Computer Decision Support Tool Intervention Group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
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
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.
Read the detailed description
This study is a prospective pharmacokinetic study of pediatric patients receiving IV vancomycin at the University of Maryland. Patients may be in the Pediatric Intensive Care Unit (PICU), Neonatal Intensive Care Unit (NICU), the Intermediate Care Unit (IMC) or the general pediatric ward.
The study design will be comparing historical controls, who are retrospective patients that had IV vancomycin dosed based on pharmacists' calculations, to prospective patients who will have vancomycin dosing based on a clinical decision support tool.
Patients requiring IV vancomycin therapy will be selected on the basis of inclusion and exclusion criteria. The study procedures will be explained to all patients and written informed consent will be obtained from each subject prior to enrollment.
Historical controls will be selected based on the same inclusion and exclusion criteria to minimize bias. Full HIPPA waiver will be used for these patients.
All patients who consent to enrolling in the study will have vancomycin dosing based on the Clinical Decision Support (CDS) tool. Results will be compared to historical controls. Patients must be enrolled within the first 24 hours of initiation of vancomycin.
Conventional hospital method- Historical Controls (standard of care)- retrospective:
Data will be collected from patients who were initiated on vancomycin using doses determined by the population parameter calculations. These patients will have a minimum of one serum creatinine documented. Trough concentrations of vancomycin will typically be collected 30 minutes prior to the 3rd dose. Multiple troughs may be collected and will be used for analysis.
Clinical Decision Support method (intervention group)- prospective:
Patient information will be entered into the decision support system to calculate vancomycin dose to be initiated in patients after consent is obtained. After enrollment into the study, the patients serum creatinine level, age (post-menstrual age if less than one year of age), sex, weight in kilograms, and height in centimeters will be entered into the CDS tool and a suggested dose (in mg/kg) and dosing interval (in hours) will be recommended. All doses recommended by the CDS tool must be approved by the pharmacist. If the dosing recommendation was, for any reason, overridden, then it will be recorded in the case report forms. The pharmacist will also calculate the AUC24/MIC manually. The proposed dose by the CDS tool should be within a 20% margin of error of the manually calculated dose. The pharmacist will have the option of using the proposed dosing regimen or standard dosing if there is concern with the proposed dose.
Once vancomycin has been infused, there will be one to two random levels drawn within the first 24 hours, and most optimally at least one level drawn prior to the second dose. Timing of these blood draws can vary and can be paired with other blood draws that are occurring at the same time. This information will then be entered into the CDS tool and the following dose(s) will be calculated. Standard trough levels will also be drawn at the discretion of the clinician and will also be used as data points in the CDS tool.
These levels will be entered back into the decision support system to determine if the target AUC/MIC is/will be attained and if necessary, calculate the new dose. If a new dose was required, another level will again be taken after the newly calculated dose was administered.
Subjects will participate in the study for up to 7 days. For all subjects, the number of blood samples collected for research-related vancomycin level determination will not exceed 5.
Serum Samples:
Blood samples will be obtained by nursing or medical staff or whoever routinely collects blood samples as part of the standard of care in that unit. When possible, blood samples obtained as part of routine clinical care for other laboratory assessments will be used in order to minimize the risk to the subjects. Samples can be drawn from a peripherally inserted central catheter (PICC), peripheral IV, central line, arterial line, or a separate blood draw. If it is drawn from the same line that was infusing the vancomycin, adequate blood waste must occur. This includes 3 mL if <2 years old, or 5 mL if >2 years old. Serum samples will be sent to the University of Maryland laboratory. Serum vancomycin levels can only be reported by the laboratory if >5 mg/L. If it is less than 5 it will be entered as 0 into the CDS.
- Being tested
- Computer Decision Support Tool Intervention Group, Matched Historical Controls
- Keywords
- computer decision support, gram positive bacterial infections, sepsis, vancomycin
- Medical subject headings
- Gram-Positive Bacterial Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Decision Support Tool Intervention GroupDevice
Also called Lyv
Computer Decision Support Tool using Bayesian estimation to dose IV vancomycin in pediatric patients using AUC24/MIC
Matched Historical ControlsOther
Also called standard of care
Vancomycin dosing based on standard hospital methods, with dose adjustments based on vancomycin trough targets
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group- Computer Decision Support Tool | Experimental | Patients enrolled in the study will be started on IV vancomycin which will be dosed based on the LYV CDS tool, which will dose patients based on AUC24/MIC. Dosing will be adjusted based on vancomycin levels that will be drawn throughout the hospital stay.
All patients prospectively enrolled into this study will be in the intervention group. Results will be compared to the retrospectively matched historical controls. Receives: Device: Computer Decision Support Tool Intervention Group |
| Matched Historical Controls | Other | Match historical controls are patients that were on IV vancomycin with dose adjustments based on vancomycin trough levels. Patients in this study arm will be retrospective patients that will be matched with the intervention group. Receives: Other: Matched Historical Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-6 hours post first dose
Secondary outcomes (3)
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.
Measured: From start to end of antibiotic therapy, or a max of 7 days
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.
Measured: From start to end of antibiotic therapy, or a max of 7 days
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
Measured: From start to end of antibiotic therapy, or a max of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start9 May 2022
- Primary completion12 Apr 2024
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gram-Positive Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The intervention group includes pediatric patients that will be started on intravenous (IV) vancomycin. Once consent is obtained, their age, weight, length, sex, serum creatinine will be entered into Lyv which will generate a dose for the patient. Levels will be drawn intermittently and dosage will be adjusted accordingly. This interventional group will be compared to matched historical controls who were treated with IV vancomycin with dosage adjustments based on trough levels.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Translational Medicine at the School of Pharmacy, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Siddhartha Dante, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911270
- Sponsor's protocol ID
- HP-00093185
- Other IDs
- T32HD087969
- Status last verified
- May 2025
- First submitted
- 24 May 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21217178Iwamoto 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.
PubMed 24062373Gerber 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.
PubMed 19463065Moise-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.
PubMed 15509186Giachetto 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.
PubMed 21057350Gous 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.
PubMed 8669599Le 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.
PubMed 23340565Kaddourah 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.
PubMed 27959707Heil 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.
PubMed 30333114Hughes 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.
PubMed 31670812
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04911270
- Acronym / sponsor ID
- HP-00093185
- Keywords
- computer decision support, gram positive bacterial infections, sepsis, vancomycin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Center for Translational Medicine at the School of Pharmacy, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective pharmacokinetic study of pediatric patients receiving IV vancomycin at the University of Maryland. Patients may be in the Pediatric Intensive Care Unit (PICU), Neonatal Intensive Care Unit (NICU), the Intermediate Care Unit (IMC) or the general pediatric ward.
The study design will be comparing historical controls, who are retrospective patients that had IV vancomycin dosed based on pharmacists' calculations, to prospective patients who will have vancomycin dosing based on a clinical decision support tool.
Patients requiring IV vancomycin therapy will be selected on the basis of inclusion and exclusion criteria. The study procedures will be explained to all patients and written informed consent will be obtained from each subject prior to enrollment.
Historical controls will be selected based on the same inclusion and exclusion criteria to minimize bias. Full HIPPA waiver will be used for these patients.
All patients who consent to enrolling in the study will have vancomycin dosing based on the Clinical Decision Support (CDS) tool. Results will be compared to historical controls. Patients must be enrolled within the first 24 hours of initiation of vancomycin.
Conventional hospital method- Historical Controls (standard of care)- retrospective:
Data will be collected from patients who were initiated on vancomycin using doses determined by the population parameter calculations. These patients will have a minimum of one serum creatinine documented. Trough concentrations of vancomycin will typically be collected 30 minutes prior to the 3rd dose. Multiple troughs may be collected and will be used for analysis.
Clinical Decision Support method (intervention group)- prospective:
Patient information will be entered into the decision support system to calculate vancomycin dose to be initiated in patients after consent is obtained. After enrollment into the study, the patients serum creatinine level, age (post-menstrual age if less than one year of age), sex, weight in kilograms, and height in centimeters will be entered into the CDS tool and a suggested dose (in mg/kg) and dosing interval (in hours) will be recommended. All doses recommended by the CDS tool must be approved by the pharmacist. If the dosing recommendation was, for any reason, overridden, then it will be recorded in the case report forms. The pharmacist will also calculate the AUC24/MIC manually. The proposed dose by the CDS tool should be within a 20% margin of error of the manually calculated dose. The pharmacist will have the option of using the proposed dosing regimen or standard dosing if there is concern with the proposed dose.
Once vancomycin has been infused, there will be one to two random levels drawn within the first 24 hours, and most optimally at least one level drawn prior to the second dose. Timing of these blood draws can vary and can be paired with other blood draws that are occurring at the same time. This information will then be entered into the CDS tool and the following dose(s) will be calculated. Standard trough levels will also be drawn at the discretion of the clinician and will also be used as data points in the CDS tool.
These levels will be entered back into the decision support system to determine if the target AUC/MIC is/will be attained and if necessary, calculate the new dose. If a new dose was required, another level will again be taken after the newly calculated dose was administered.
Subjects will participate in the study for up to 7 days. For all subjects, the number of blood samples collected for research-related vancomycin level determination will not exceed 5.
Serum Samples:
Blood samples will be obtained by nursing or medical staff or whoever routinely collects blood samples as part of the standard of care in that unit. When possible, blood samples obtained as part of routine clinical care for other laboratory assessments will be used in order to minimize the risk to the subjects. Samples can be drawn from a peripherally inserted central catheter (PICC), peripheral IV, central line, arterial line, or a separate blood draw. If it is drawn from the same line that was infusing the vancomycin, adequate blood waste must occur. This includes 3 mL if <2 years old, or 5 mL if >2 years old. Serum samples will be sent to the University of Maryland laboratory. Serum vancomycin levels can only be reported by the laboratory if >5 mg/L. If it is less than 5 it will be entered as 0 into the CDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group includes pediatric patients that will be started on intravenous (IV) vancomycin. Once consent is obtained, their age, weight, length, sex, serum creatinine will be entered into Lyv which will generate a dose for the patient. Levels will be drawn intermittently and dosage will be adjusted accordingly. This interventional group will be compared to matched historical controls who were treated with IV vancomycin with dosage adjustments based on trough levels.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group- Computer Decision Support Tool | Experimental | Device: Computer Decision Support Tool Intervention GroupPatients enrolled in the study will be started on IV vancomycin which will be dosed based on the LYV CDS tool, which will dose patients based on AUC24/MIC. Dosing will be adjusted based on vancomycin levels that will be drawn throughout the hospital stay. All patients prospectively enrolled into this study will be in the intervention group. Results will be compared to the retrospectively matched historical controls. |
| Matched Historical Controls | Other | Other: Matched Historical ControlsMatch historical controls are patients that were on IV vancomycin with dose adjustments based on vancomycin trough levels. Patients in this study arm will be retrospective patients that will be matched with the intervention group. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Decision Support Tool Intervention GroupAlso: LyvComputer Decision Support Tool using Bayesian estimation to dose IV vancomycin in pediatric patients using AUC24/MIC | Device | Intervention Group- Computer Decision Support Tool |
| Matched Historical ControlsAlso: standard of careVancomycin dosing based on standard hospital methods, with dose adjustments based on vancomycin trough targets | Other | Matched Historical Controls |
Primary outcome
AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method
Time frame: 2-6 hours post first dose
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.
3 secondary outcomes
To characterize vancomycin pharmacokinetics and evaluate the factors that affect variability in achievement of an AUC24/MIC > 400 in pediatric patients
Time frame: From start to end of antibiotic therapy, or a max of 7 days
To evaluate the incidence of nephrotoxicity for dosing vancomycin using the decision support tool compared to dosing using the current hospital method
Time frame: From start to end of antibiotic therapy, or a max of 7 days
To evaluate the accuracy of the clinical decision support system in predicting the AUC24/MIC
Time frame: From start to end of antibiotic therapy, or a max of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 21217178Liu 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.
- Background: PubMed 24062373Iwamoto 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.
- Background: PubMed 19463065Gerber 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.
- Background: PubMed 15509186Moise-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.
- Background: PubMed 21057350Giachetto 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.
- Background: PubMed 8669599Gous 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.
- Background: PubMed 23340565Le 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.
- Background: PubMed 27959707Kaddourah 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.
- Background: PubMed 30333114Heil 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.
- Background: PubMed 31670812Hughes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Decision Support Tool Intervention Group in people with Gram-Positive Bacterial Infections and Vancomycin, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method (time frame: 2-6 hours post first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911270, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.