Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

Pharmacokinetics Clinical Trial

— DATATDM  

Official title:

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06427317
• Other study ID #: 21HH7287
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: March 19, 2027

Study information

• Verified date: May 2024
• Source: Imperial College London
• Contact: Suzy Williams
• Phone: +44 (0) 20 3313 2732
• Email: suzanne.williams[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 323
• Est. completion date: March 19, 2027
• Est. primary completion date: March 19, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Drug Monitoring
• Drug-Related Side Effects and Adverse Reactions
• Infections
• Infections, Bacterial
• Pharmacokinetics

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.	Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved	3 years
Secondary	Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.	Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.	3 years
Secondary	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.	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.	3 years
Secondary	Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.	Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.	3 years
Secondary	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.	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.	3 years
Secondary	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	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	3 years