Evaluating antibiotic effectiveness in patients with infections
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
Imperial College London · NCT06427317
This study is testing how well beta-lactam antibiotics work for patients with infections by checking if they get the right amount of the medicine in their system to help them recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 323 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06427317 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine how many patients at Imperial College Healthcare NHS Trust receiving beta-lactam antibiotics achieve the necessary drug concentration targets for effective treatment. By analyzing routinely collected clinical data and drug concentration samples, the study seeks to understand the relationship between clinical variables and treatment outcomes. It also aims to identify gaps in current dosing practices and prioritize areas for further research on drug optimization. Participants will be monitored during their infection management, providing valuable insights into antimicrobial effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are being treated for infections and have received beta-lactam antibiotics within the last 48 hours.
Not a fit: Patients under 18, those with severe blood disorders, or those receiving palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antibiotic dosing strategies, enhancing treatment outcomes and reducing the risk of antimicrobial resistance.
How similar studies have performed: While the approach of optimizing antibiotic dosing is well-recognized, this specific observational study may provide novel insights into real-world dosing effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Alison Holmes, MD — Imperial College London
- Study coordinator: Suzy Williams
- Email: suzanne.williams@imperial.ac.uk
- Phone: +44 (0) 20 3313 2732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions