Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)

NCT05950984 | Completed

• 1 other identifier: 2022.0286
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment). Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate. We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment. In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.

Conditions

Infection, Bacterial; Antibiotic Side Effect; Antibiotic Resistant Infection; Sepsis; Septic Shock; Bacteremia; Critical Illness; Adult Children

Keywords

Vancomycin; Pharmacokinetics; Accuracy; Medical Device; Digital; Data; Protein Binding; Critical Illness; Drug Infusion Pump; Electronic Prescribing and Administration System; Point of Care; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Objective Function Value

  Pharmacokinetic model fit determined quantitively by Objective Function Value (2.log likelihood) using vancomycin administration time data recorded by patient's bedside drug infusion devices compared to manually recorded data

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

Secondary Outcomes (4)

• Participant Vancomycin Volume of Distribution

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

• Participant Vancomycin Clearance

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

• Participant 24-hour Area Under the Vancomycin Concentration Time Curve (AUC)

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

• Participant 24-hour AUC:MIC Ratio

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

Other Outcomes (6)

• Association Between Participant's Mean 24-hour AUC:MIC and Microbiological Cure

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

• Association Between Participant's Mean 24-hour AUC:MIC and Length of Intensive Care (ICU) Unit Stay

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

• Association Between Participant's Mean 24-hour AUC:MIC and Infection Related Mortality

  Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin

Study Arms (1)

Critically Ill Adults and Children

Adults and children from 1-day old admitted to a critical care unit.

Other: Drug Infusion Pump Monitoring

Interventions

Drug Infusion Pump Monitoring OTHER

Intravenous vancomycin administration accuracy will be determined by comparing data obtained from drug infusion pumps with manually input administration times from the electronic Prescribing and Medicines Administration (ePMA) system.

Critically Ill Adults and Children

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children admitted to an intensive care unit and administered intravenous vancomycin for prevention/treatment of an infection

You may qualify if:

• Admitted to either adult or paediatric intensive care unit (ICU) and receiving intravenous vancomycin (continuous or intermittent infusion only), to prevent or treat a clinical infection
• Informed consent form signed by participant/parent/legal guardian/legal representative (as determined by age group/capacity, consent may be retrospective) or signed informed personal/nominated consultee declaration
• Age from 1-day since birth

You may not qualify if:

• Previous enrolment into this study
• Treating clinician feels participant unlikely to survive beyond 48-hours from enrolment or treatment has been withdrawn for reasons of palliation
• Absence of in-dwelling vascular access from which samples may be drawn or removal of in-dwelling access prior to retrieval of a 3rd blood sample (for assay of vancomycin concentration)
• Non-continuous renal replacement (i.e. intermittent haemodialysis/ peritoneal dialysis)
• Hypersensitivity or allergies to vancomycin, its excipients, or the infusion fluid
• Treatment outside an ICU area
• In paediatrics:
• Required blood sampling exceeds 3% of total blood volume in a four-week period or 1% at any single time (European Medicines Agency, 2009)
• Where there is disagreement between child consent/assent and parental/ legal guardian consent/assent

Sponsors & Collaborators

• St George's, University of London: lead
• University College, London: collaborator

Study Sites (1)

St Georges University Hospitals NHS Foundation Trust

London, London, SW17 0QT, United Kingdom

Location

Related Publications (2)

• Oakley R, Bakrania P, Yau T, Standing J, Lonsdale D. Variable adherence to and effectiveness of a vancomycin continuous infusion protocol within ICUs at a London tertiary-care hospital: a single-centre retrospective service evaluation 2022;4:dlac004.036. https://doi.org/10.1093/jacamr/dlac004.036

  BACKGROUND

• Correction to: Improving adherence to and effectiveness of an adult critical care vancomycin continuous infusion protocol: a pilot quality improvement and administration data accuracy project. JAC Antimicrob Resist. 2023 Jun 8;5(3):dlad075. doi: 10.1093/jacamr/dlad075. eCollection 2023 Jun.

  PMID: 37305849 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Sepsis; Shock, Septic; Bacteremia; Critical Illness

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: July 18, 2023
• Study Start: October 30, 2023
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: May 18, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)