Infections, BacterialDATATDMNCT06427317
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
An observational study of Infections, Bacterial and Pharmacokinetics, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Bacterial, Pharmacokinetics, Drug Monitoring
- How many people
- 323 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2024to 19 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As per inclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Richard Wilson, MPharm contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Suzy Williams, +44 (0)20 3313 2732, suzanne.williams@imperial.ac.uk
About this study
Official title: Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
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.
Read the 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
- Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Bacterial Infections, Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 3 years
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.
Measured: 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.
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.
Measured: 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
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start19 Mar 2024
- Primary completion19 Mar 2027 (estimated)
- Study completion19 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, BacterialStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Holmes, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427317
- Sponsor's protocol ID
- 21HH7287
- Acronym
- DATATDM
- Status last verified
- May 2024
- First submitted
- 27 Mar 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
- ClinicalTrials.gov ID
- NCT06427317
- Acronym / sponsor ID
- DATATDM / 21HH7287
- Conditions
- Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 19 Mar 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As per inclusion criteria
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved
5 secondary outcomes
Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved.
Time frame: 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.
Time frame: 3 years
Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response.
Time frame: 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.
Time frame: 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
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Wilson, MPharm contact
Alison Holmes, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Bacterial and Pharmacokinetics, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzy Williams (+44 (0) 20 3313 2732, suzanne.williams@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.