Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
Overview
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.
Primary outcome measures
- Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved. [Time frame: 3 years]
Secondary outcome measures (5)
- Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved. [Time frame: 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. [Time frame: 3 years]
- Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response. [Time frame: 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. [Time frame: 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 [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
Identifiers
NCT: NCT06427317 · 21HH7287