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Completed

NCT Number: NCT05950984

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

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.

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Key information

Conditions

Infection, Bacterial Adult Children Antibiotic Resistant Infection Antibiotic Side Effect Bacteremia Bacterial Infections Bacterial Infections and Mycoses Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Georges University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Objective Function Value

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

    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

Secondary outcomes

  1. Participant Vancomycin Volume of Distribution

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

    Calculation of participant's vancomycin volume of distribution (litres) using non-linear mixed effects modelling methods from obtained non-protein bound and total vancomycin concentrations and patient's drug infusion device obtained administration time data

  2. Participant Vancomycin Clearance

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

    Calculation of participant vancomycin clearance (litres/hour) using non-linear mixed effects modelling methods using obtained non-protein bound and total vancomycin concentrations and participant's drug infusion device derived administration time data

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

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

    Calculation of participant's AUC (milligrams.hour/litre) using obtained non-protein bound and total vancomycin concentrations and participant's drug infusion device derived administration time data

  4. Participant 24-hour AUC:MIC Ratio

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

    Calculation of the area under the 24-hour non-protein bound and total vancomycin concentration AUC/bacterial minimum inhibitory concentration (MIC) ratio using an empiric MIC of 1mg/L or MIC of obtained isolates (if available) using trapezial rule or vancomycin dose and calculated clearance

Other outcomes

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

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

    Microbiological cure defined as eradicated baseline microorganisms and no new microorganisms are identified via bacterial cultures (if available), plus, the patient has received allocated treatment for at least 2-days with no modification or a failure

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

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

    ICU stay quantified by days since admission, categories include: <2 days, < 7 days, <14 days, >14 days

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

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

    Cause of mortality will be derived from participant's medical notes

  4. Association Between Participant's Mean 24-hour AUC:MIC and Infection related ICU Re-admission

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

    Cause of re-admission will be derived from participant's medical notes

  5. Association Between Participant's Mean 24-hour AUC:MIC and Vancomycin Associated Acute Kidney Injury (AKI)

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

    AKI defined by Kidney Disease: Improving Global Outcomes (KDIGO) Criteria

  6. Association Between Participant's Mean 24-hour AUC:MIC and Adult National Early Warning Score (NEWS2) or Paediatric Early Warning Score (PEWS3)

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

    Warning scores calculated on day of (and closest to) first dose of study recorded vancomycin treatment course, between 2-3 days since vancomycin course initiation and at end of vancomycin course or 28 days from first study recorded administration of vancomycin

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • University College, London

Registry information

Official study title

An Investigation Into How Medical Device Obtained Variables Influence the Pharmacokinetic Profile of Vancomycin: a Paediatric and Adult Critical Care Feasibility Assessment at a London Tertiary-care Hospital

Acronym: MD-PK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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