Infection, BacterialMD-PKNCT05950984
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
An observational study of Infection, Bacterial and Antibiotic Side Effect, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Infection, Bacterial, Antibiotic Side Effect, Antibiotic Resistant Infection
- What is being tested?
- Drug Infusion Pump Monitoring
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2023to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children admitted to an intensive care unit and administered intravenous vancomycin for prevention/treatment of an infection
Who may be able to join
- 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
Who cannot join
- 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- Treating clinician feels participant unlikely to survive beyond 48-hours from enrolment or treatment has been withdrawn for reasons of palliation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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Georges University Hospitals NHS Foundation Trust
London, London, SW17 0QT
About this study
Official 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
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.
Read more
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
- Being tested
- Drug Infusion Pump Monitoring
- 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
- Medical subject headings
- Bacterial Infections, Sepsis, Shock, Septic, Bacteremia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Infusion Pump MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Adults and Children | Adults and children from 1-day old admitted to a critical care unit. Receives: Other: Drug Infusion Pump Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin
Participant Vancomycin Clearance
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
Measured: 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)
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
Measured: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin
Participant 24-hour AUC:MIC Ratio
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
Measured: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start30 Oct 2023
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950984
- Sponsor's protocol ID
- 2022.0286
- Acronym
- MD-PK
- Status last verified
- Jan 2024
- First submitted
- 29 May 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Fully anonymised collected patient data may be shared if consent provided with select research collaborators
Publications
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
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.
PubMed 37305849
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05950984
- Acronym / sponsor ID
- MD-PK / 2022.0286
- Conditions
- Infection, Bacterial, Antibiotic Side Effect, Antibiotic Resistant Infection, Sepsis, Septic Shock, Bacteremia
- Keywords
- Vancomycin, Pharmacokinetics, Accuracy, Medical Device, Digital, Data, Protein Binding, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Adults and Children | – | Other: Drug Infusion Pump MonitoringAdults and children from 1-day old admitted to a critical care unit. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children admitted to an intensive care unit and administered intravenous vancomycin for prevention/treatment of an infection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Infusion Pump MonitoringIntravenous 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. | Other | Critically Ill Adults and Children |
Primary outcome
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
4 secondary outcomes
Participant Vancomycin Volume of Distribution
Time frame: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin
Participant Vancomycin Clearance
Time frame: 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)
Time frame: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- BackgroundOakley 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: PubMed 37305849Correction 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.
- Individual participant dataSharing planned: No. Fully anonymised collected patient data may be shared if consent provided with select research collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bacterial and Antibiotic Side Effect, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Function Value (time frame: Within collection of 15 vancomycin serum concentrations or 28 days from first study recorded administration of vancomycin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.