Clinical trial NCT06427317: Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
Official title: Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections, Bacterial
Pharmacokinetics
Drug Monitoring
Drug-Related Side Effects and Adverse Reactions
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As per inclusion criteria

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.
timeFrame: 3 years
Secondary outcomes:
measure: Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Alison Holmes, MD
role: PRINCIPAL_INVESTIGATOR
References: