Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427317
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-27
Brief Title:
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DATATDM
Brief 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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None