NCT05950984

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2023-07-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: United Kingdom