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Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

Sponsor: Imperial College London

NCT ID: NCT06427317

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
323
Started
2024-03-19
Last checked
2024-05

Plain English Summary

What is this study?

  • • Testing a new treatment for infections, bacterial
  • • Clinical study - 323 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with infections, bacterial

Where?

  • • London - Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Infections, BacterialPharmacokineticsDrug MonitoringDrug-Related Side Effects and Adverse Reactions

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓Delirium which may be caused or exacerbated by having an infection.

Who cannot take part

  • ✗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...
  • ✗Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
See the full 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.

Where Is This Study? (1 UK site)

Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Suzy Williams

Sponsor contact

CONTACT

+44 (0) 20 3313 2732 suzanne.williams@imperial.ac.uk

Richard Wilson, MPharm

Sponsor contact

CONTACT

richard.wilson@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-05