Active not recruitingOBSERVATIONAL

A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes

This study investigates how having a penicillin allergy affects patients, particularly those admitted to hospital with COVID-19. Many people believe they have a penicillin allergy, but often don't when tested. This can lead to them being given less effective antibiotics, which may have more side effects and could contribute to bacteria becoming resistant to medicines. The research aims to understand if patients with a penicillin allergy label have more antibiotic-resistant bacteria in their mouth and gut. It also wants to see if removing an incorrect penicillin allergy label can reduce these resistant bacteria. Ultimately, the study hopes to improve how we use antibiotics and ensure patients get the most suitable treatment.

At a glance

Status

Active not recruiting

Sponsor

University of Leeds

Enrolment target

214

Start

30 Nov 2021

Estimated completion

01 Dec 2025

Penicillin Allergy Antimicrobial Drug Resistance AMR

What is this study about?

Imagine you're unwell and need antibiotics, but your medical records say you're allergic to penicillin – one of the most common and effective antibiotics. This often means doctors have to choose other antibiotics that might not work as well, could cause more side effects, and might even make bacteria stronger against medicines over time. Interestingly, many people who think they have a penicillin allergy actually don't when tested by a specialist. This means they could be missing out on the best treatment because of an allergy label that isn't true.

This study wants to understand this problem better. Researchers will look at how having a penicillin allergy affects how patients are treated, especially those who were in hospital with COVID-19 and needed antibiotics. They're also keen to find out if people with a penicillin allergy on their records tend to have more bacteria in their mouth and gut that are resistant to antibiotics. These 'good' bacteria in our bodies help us stay healthy, but antibiotics can sometimes disrupt them, leading to resistant bacteria growing stronger.

The study hopes to show that if someone's penicillin allergy label is found to be incorrect and removed, the levels of these resistant bacteria in their body might reduce. By understanding these links, the study aims to help doctors make better choices about antibiotics, ensuring patients get the most effective treatment while also trying to slow down the problem of antibiotic resistance, which is when bacteria learn to fight off medicines.

Key takeaways

Many reported penicillin allergies might not be true allergies.
Incorrect allergy labels can lead to less effective antibiotic treatments.
This study investigates links between penicillin allergy and antibiotic resistance.
It aims to see if removing an incorrect allergy label can reduce resistant bacteria.
The research could help improve future antibiotic use and patient care.

Who may be eligible?

This study is looking for different groups of people, depending on which part of the research they fit into.

For one part of the study, they are looking at information from adults (anyone over 16) who had COVID-19 and were in an NHS hospital between February and June 2020. This part of the study uses existing records, so you don't need to do anything if you were one of these patients, but your information might be used.

Another part is for adults (18 or over) who either have a penicillin allergy recorded, or who don't have a penicillin allergy but are similar in age and sex to someone who does. You would need to have taken antibiotics in the last two years and be willing to give saliva and/or poo samples. There's also a part of the study for people who are already taking part in another study called ALABAMA and are willing to provide samples.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a penicillin allergy recorded in your notes, or are you similar in age/sex to someone who does?
Have you taken antibiotics in the last two years?
Are you able and willing to provide saliva and/or stool samples?
Are you currently taking part in the ALABAMA trial?

Answer every question to see your result.

What does participation involve?

This study is made up of different parts. For some, researchers will look at existing medical information from people treated for COVID-19 in NHS hospitals in 2020. You would not need to do anything for this part.

For other parts of the study, if you match the criteria, you might be asked to provide samples of your saliva and/or stool (poo). This would involve collecting the samples yourself at home or during a visit, and then sending them back to the study team. They will also collect some information about your health and any antibiotics you've taken recently. The specific number of visits or the exact duration of your participation would depend on which part of the study you are eligible for, but providing samples is generally a one-off or short-term commitment.

Potential risks and benefits

Taking part in this study could help us understand more about penicillin allergies and antibiotic resistance, which might lead to better treatments for everyone in the future. For some parts of the study, you might only be providing samples, which generally carries very low risk, though collecting samples like saliva or stool might feel a bit unusual. There are no direct medical benefits to you from participating. You are free to change your mind and withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Leeds Teaching Hospitals NHS trust
Verified postcode
Leeds, United Kingdom

Common questions

What is antibiotic resistance?

Antibiotic resistance is when bacteria change and learn to fight off the medicines meant to kill them. This can make infections harder to treat.

Why is a penicillin allergy label a problem if it's not real?

If you have an incorrect penicillin allergy label, doctors might use other antibiotics that are less effective, have more side effects, and could make antibiotic resistance worse.

What is the 'microbiome'?

The microbiome refers to all the tiny living things, like bacteria, that live naturally in and on our bodies, especially in our gut and mouth, helping us stay healthy.

Will this study change my medical treatment?

No, this study is for research purposes. Any changes to your medical treatment would be discussed with your own doctor.

How can I find out if my penicillin allergy is real?

If you suspect your penicillin allergy might not be real, you should talk to your GP or a healthcare professional about getting tested by an allergy specialist.