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

NCT05950984 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

OTHER

Drug Infusion Pump Monitoring

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.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-08-28
Completion
2024-08-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05950984 on ClinicalTrials.gov