Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

NCT06427317 | Recruiting

• 1 other identifier: 21HH7287
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.

  3 years

• 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

• Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.

  3 years

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As per inclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with restricted liberty, prisoners or under legal protection.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sera, saliva, urine, nasal mucous, CSF, renal replacement fluid, CSF

MeSH Terms

Conditions

Bacterial Infections; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders

Study Officials

• Alison Holmes, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzy Williams

CONTACT

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

Richard Wilson, MPharm

CONTACT

richard.wilson@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: May 23, 2024
• Study Start: March 19, 2024
• Primary Completion (Estimated): March 19, 2027
• Study Completion (Estimated): March 19, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

GB (1)