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

St George's, University of London

Status

Completed

Conditions

Antibiotic Side Effect

Bacteremia

Critical Illness

Antibiotic Resistant Infection

Septic Shock

Adult Children

Sepsis

Infection, Bacterial

Treatments

Other: Drug Infusion Pump Monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT05950984

2022.0286

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

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