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

Imperial College London

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06427317

21HH7287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.