## Protocol Section
### Identification Module
**NCT ID:** NCT06427317

**Acronym:** DATATDM

**Brief Title:** Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

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

#### Organization Study ID Info
**ID:** 21HH7287
#### Organization
**Class:** OTHER
**Full Name:** Imperial College London
### Status Module
#### Completion Date
**Date:** 2027-03-19

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-03-19

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Imperial College London

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Infections, Bacterial

- Pharmacokinetics

- Drug Monitoring

- Drug-Related Side Effects and Adverse Reactions

### Design Module

#### Bio Spec

**Description:** Sera, saliva, urine, nasal mucous, CSF, renal replacement fluid, CSF

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 323

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved

**Measure:** Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.

**Time Frame:** 3 years

#### Secondary Outcomes

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

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

**Time Frame:** 3 years

**Description:** 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.

**Measure:** 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.

**Time Frame:** 3 years

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

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

**Time Frame:** 3 years

**Description:** 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.

**Measure:** 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.

**Time Frame:** 3 years

**Description:** 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

**Measure:** 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

**Time Frame:** 3 years

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** As per inclusion criteria

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** suzanne.williams@imperial.ac.uk

**Name:** Suzy Williams

**Phone:** +44 (0) 20 3313 2732

**Role:** CONTACT

**Contact 2:**

**Email:** richard.wilson@imperial.ac.uk

**Name:** Richard Wilson, MPharm

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** suzanne.williams@imperial.ac.uk

- **Name:** Suzy Williams

- **Phone:** +44 (0)20 3313 2732

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Imperial College Healthcare NHS Trust

**Status:** RECRUITING

**Zip:** W12 0HS

#### Overall Officials

**Official 1:**

**Affiliation:** Imperial College London

**Name:** Alison Holmes, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30303

- Name: Drug-Related Side Effects and Adverse Reactions

- Relevance: HIGH

- As Found: Drug-Related Side Effects and Adverse Reactions

- ID: M4722

- Name: Bacterial Infections

- Relevance: HIGH

- As Found: Infection, Bacterial

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000064420

- Term: Drug-Related Side Effects and Adverse Reactions

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
