RecruitingOBSERVATIONAL

Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment

Researchers at Imperial College Healthcare NHS Trust are looking into how well antibiotics, specifically a type called beta-lactams, work in patients being treated for infections. The main goal is to see if the antibiotics reach the right concentration in the body to effectively fight the infection, without causing too many side effects. This is really important because we want to make sure these vital medicines work as best they can, helping patients get better and also reducing the chance of bacteria becoming resistant to them. By understanding this better, we can improve how antibiotics are used for everyone. Participants' health information will be collected, and some samples will be taken to measure antibiotic levels.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

323

Start

19 Mar 2024

Estimated completion

19 Mar 2027

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

What is this study about?

Infections are a common health problem, and antibiotics are essential medicines used to treat them. However, bacteria can sometimes become resistant to antibiotics, making infections harder to treat. This is a big concern for healthcare professionals worldwide. This study focuses on a specific type of antibiotic called beta-lactams, which are widely used.

The main purpose of this research is to understand if these antibiotics are reaching the right levels in a patient's body when they are being treated for an infection outside of intensive care. Think of it like this: if you're taking a medicine, you want to be sure you're getting enough for it to work properly, but not too much that it causes problems. For antibiotics, getting the levels just right is key to successfully fighting the infection, preventing side effects, and helping to stop drug resistance from happening.

By carefully looking at the information from patients receiving these antibiotics at Imperial College Healthcare NHS Trust, and by analysing samples to measure antibiotic levels, the researchers hope to find better ways to use these medicines. This could help doctors to adjust antibiotic doses more effectively in the future, improving treatment for infections and contributing to the fight against antibiotic resistance.

Key takeaways

Aims to improve antibiotic treatment for infections.
Checks if antibiotics reach the right levels in patients.
Focuses on common antibiotics called beta-lactams.
Information gathered from medical records and samples.
Helps fight antibiotic resistance.
No change to your infection treatment.

Who may be eligible?

This study is looking for adults aged 18 or older who are being treated for an infection at Imperial College Healthcare NHS Trust. You would need to be currently taking, or about to start taking, a specific type of antibiotic called a beta-lactam within a 48-hour timeframe.

Even if you are very unwell or temporarily unable to make decisions (for example, due to a severe infection making you disoriented, or if you're sedated), you might still be able to join the study through a consultee who can make decisions on your behalf.

However, you wouldn't be able to take part if you are under 18, have certain serious blood conditions (like very low iron or blood clotting issues), are receiving end-of-life care, are already in another clinical trial that prevents participation in other studies, or are in a situation where your liberty is restricted (like being in prison).

Quick self-check

Are you 18 years old or older?
Are you being treated for an infection at Imperial College Healthcare NHS Trust?
Are you taking, or about to take, a beta-lactam antibiotic?
Do you not have certain serious blood conditions?
Are you not currently in another clinical trial that would prevent you from joining?
Are you not receiving end-of-life care.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your journey will involve careful observation during your routine care for an infection at Imperial College Healthcare NHS Trust. You will first be asked to give your informed consent, which means you'll have all the information and time to decide if you want to participate. The research team will then collect some of your routine health information directly from your electronic medical records. Additionally, you will be asked to provide some samples, which will be analysed to measure the levels of the antibiotic in your body. The study aims to observe participants during their usual hospital stay for infection treatment, so there are no extra hospital visits required beyond your standard care. The total duration of your participation will depend on how long you are being treated for your infection and when the samples are collected, but it's integrated into your normal treatment pathway.

Potential risks and benefits

Taking part in this study offers a potential benefit by helping us understand how to use antibiotics more effectively, which could lead to better infection treatment for future patients and help prevent antibiotic resistance. For you personally, there is no direct medical benefit as the study simply observes your current treatment. The main risk involves providing additional samples for testing, which may involve minor discomfort or bruising similar to a standard blood test. All personal health information will be handled with strict confidentiality. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Imperial College Healthcare NHS Trust
London, United Kingdom· Recruiting

Common questions

What is an 'antimicrobial target'?

It means the ideal level of antibiotic in your body needed to effectively fight the infection without causing too many side effects.

What are beta-lactam antibiotics?

These are a common and important group of antibiotics, like penicillin, that doctors use to treat many different bacterial infections.

Will I receive different treatment if I join the study?

No, you will receive the same standard treatment for your infection at Imperial College Healthcare NHS Trust as you would if you weren't in the study.

Do I have to give extra blood samples?

Yes, you would be asked to provide some samples, likely blood, to measure the antibiotic levels. This would be in addition to any samples taken for your usual care.

What is antibiotic resistance?

It's when bacteria change over time and stop responding to antibiotics, making infections much harder to treat.

How to find out more

Suzy Williams

suzanne.williams@imperial.ac.uk +44 (0) 20 3313 2732 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.