Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment (DATATDM)

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management

The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics; Drug-Related Side Effects and Adverse Reactions; Infections, Bacterial; Drug Monitoring

Detailed Description

To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance.

Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection.

This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies.

Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.

• Study Type: Observational
• Enrollment (Estimated): 323

Contacts and Locations

• Study Contact: Name: Suzy Williams; Phone Number: +44 (0) 20 3313 2732; Email: suzanne.williams@imperial.ac.uk
• Study Contact Backup: Name: Richard Wilson, MPharm; Email: richard.wilson@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Imperial College Healthcare NHS Trust
    • Contact: Suzy Williams; Phone Number: +44 (0)20 3313 2732; Email: suzanne.williams@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

As per inclusion criteria

Description

Inclusion Criteria:

18 years of age or above.

• Under follow-up for management of infection at Imperial College NHS Trust
• Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).
• Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):
• Delirium which may be caused or exacerbated by having an infection.
• Suspected/confirmed central nervous system infection.
• Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection.

Exclusion Criteria:

• Less than 18 years of age

  • Severe anaemia (Hb < 70g/l)
  • Platelets < 50x10^9/l, INR >1.5 or other known blood clotting impairment
  • Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.
  • Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
  • Patients with restricted liberty, prisoners or under legal protection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.	Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.	Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.	3 years
Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.	Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial.	3 years
Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.	Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.	3 years
Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.	Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation.	3 years
Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies	Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies	3 years

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Alison Holmes, MD, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): March 19, 2027

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Bacterial Infections and Mycoses; Infections; Drug-Related Side Effects and Adverse Reactions; Bacterial Infections
• Other Study ID Numbers: 21HH7287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No