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NIHR Leeds CRF supports new study into Penicillin allergy testing to fight antibiotic resistance  

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An image of a person holding white tablets in their left hand

A trial supported by NIHR Leeds CRF into removing incorrect penicillin allergy labels on GP records could combat antibiotic resistance and save lives, an NIHR-funded clinical trial led by the University of Leeds has found. 

Penicillins are first-choice antibiotics for many common infections, but more than one in 15 UK adults have a penicillin allergy label on their medical records. In the event of an infection, they will be prescribed alternative antibiotics which can be less effective or have more side effects. This can result in several prescriptions being issued to control the infection, which affects wellbeing and contributes to antimicrobial resistance.  

The study published in the Lancet Primary Care, which was supported by NIHR Leeds Clinical Research Facility in Leeds, found that that almost nine in ten (88%) patients with a penicillin allergy label were not truly allergic after testing, and had their allergy label safely removed. More than 800 patients were included in the trial. 

Verifying the accuracy of penicillin allergy labels could help patients to access more effective antibiotics, which is crucial as the threat of antimicrobial resistance to public health grows. The ALABAMA (ALlergy AntiBiotics And Microbial resistAnce) trial, coordinated by the University of Oxford Primary Care Clinical Trials Unit, was created to help find solutions for this issue.  

An image of Dr Jonathan Sandoe
Dr Jonathan Sandoe was joint lead author on the ALABAMA study

Joint lead author Dr Jonathan Sandoe, Associate Clinical Professor in Microbiology in the University of Leeds School of Medicine and Leeds Teaching Hospitals NHS Trust, said: “Antibiotics have been life-saving drugs since the late 1930s, but we are now in an era where microbes are evolving to resist the effects of current antibiotics. The global challenge of antibiotic resistance is causing people to die of common infections – so it is vital to find ways to improve how antibiotics are used. Assessing people with penicillin allergy labels is one way we can achieve this.” 

Read the full story via the University of Leeds website 

Charity partnership backs neuromuscular research powered by NIHR Leeds CRF, enabling life-changing trials for families

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An image of Austin in a hospital bed with him mother Maxine and Dr Anne-Marie Childs sitting at the side of the bed.

Duchenne UK and Leeds Hospitals Charity have partnered to fund two new roles within the Neuromuscular Service over the next five years. Together, they are contributing more than £300,000 to support this specialist team, recognising its status as a centre of excellence in paediatric neuromuscular research.

As part of the service, NIHR Leeds Clinical Research Facility (CRF) Children’s Site delivers pioneering clinical trials, exploring innovative treatments for neuromuscular conditions at Leeds Children’s Hospital and has consistently led the way in this area of research.

The NIHR Leeds CRF has been the first site in the UK to recruit to several clinical studies for Duchenne muscular dystrophy (DMD), the most common and severe form of childhood muscular dystrophy. Most recently, the children’s research unit delivered a landmark Phase 1 trial investigating a promising new treatment for DMD.

11-year-old Austin was diagnosed with the condition in November 2015, at just two years old. Austin’s mother Maxine initially thought he had a virus and took him to hospital, where he spent the next month having tests.

Three years ago, Austin began a trial at the NIHR Clinical Research Facility Children’s Site. Austin has received over 130 infusions, and though he knows he will lose the ability to walk, he tells Maxine he takes part in the trials because, ‘I want to help boys in the future to walk longer.’

For Austin’s family, the opportunity to participate in clinical trials has been a lifeline, offering hope to other families to find better treatments and eventually a cure. Austin’s current trial ends in September, but Maxine says if he chooses to continue to take part in research trials, they will continue to visit hospitals up and down the country.

‘From the moment Austin was diagnosed, our world changed. Nothing could have prepared me for the grief of knowing his life would be cut short. But through the darkness, clinical trials gave us hope. The support from the team in Leeds has been incredible; they’ve become like family. Research is vital, not just for medical breakthroughs, but for families like ours to feel less alone. Austin is paving the way, and we’re so proud of him.’

The funding from Duchenne UK and Leeds Hospital Charity will go towards funding the role of Consultant Paediatric Neurologist Dr Anne-Marie Childs. Dr Childs said the funding would be enable the service to plan for the future.

‘We’re incredibly grateful to both Leeds Hospitals Charity and Duchenne UK for their grant funding to support the children’s neuromuscular service. This investment will allow us to attract the best people to work in the Leeds neuromuscular team and create new opportunities for clinical trials that can support even more families. Neuromuscular conditions have a devastating impact, not just on the child affected but the whole family; funding like this gives hope that new treatments and new drugs can be developed.’

NIHR Leeds CRF at 20th UKCRF Network Conference

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The NIHR Leeds CRF team standing on the steps at the conference.

NIHR Leeds CRF recently attended the 20th annual UKCRF Network Conference in Birmingham, the first to be held jointly with the NIHR Biomedical Research Centres.

Twenty-three of our team members, representing the broad scope of our work in clinical research, joined hundreds of delegates from across the UK to exchange insights and learn about the latest developments in healthcare research. It was an opportunity to create new connections and emphasised the importance of collaboration in delivering world-class research which is truly impactful.

Team members at the conference dinner.
An image of Karl Ward and Helen Radford giving with Karl Ward speaking at the lectern in front of a slide with research colleagues photographed on it.
Four colleagues standing in front of the conference banner reading "Co-operate to Translate".
The NIHR Leeds CRF team standing on the steps at the conference.

Dr Helen Radford and Karl Ward delivered an outstanding session at the conference on the ever-growing role of artificial intelligence in advancing research. Dr Radford also shared valuable reflections into attracting commercial clinical research, and Karl Ward presented our approach for best practice in training and embedding research within NHS teams.

We were also privileged to hear from our patient and public involvement and engagement (PPIE) Manager Hanif Ismail and patient representative Barrow Sawo, who spoke compellingly about overcoming challenges in public engagement, highlighting inclusive strategies for meaningful collaboration.

The team had a great experience celebrating their successes at the conference, where they not only presented their research to peers but also had the opportunity to meet and exchange ideas with other leaders in clinical research delivery. Our thanks to the organisers, we are already looking forward to next year’s conference!

Natasha Allergy Research Foundation visit to Leeds Children’s Hospital to meet Clinical Research Facility study participants  

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An image from the visit with clinicians and visitors in a ward setting.

On Monday 7 July, Leeds Children’s Hospital and the NIHR Clinical Research Facility (CRF) Children’s Site welcomed visitors from The Natasha Allergy Research Foundation (NARF). Visitors from Natasha’s Foundation and their partner organisations came to see first-hand how The Natasha Clinical Trial is helping allergy patients in Leeds.

Children as young as two are taking part in the £2.7 million Natasha Clinical Trial across nine NHS hospitals including Leeds Children’s Hospital, part of Leeds Teaching Hospitals NHS Trust. The trial aims to demonstrate the effectiveness of commonly available foods to treat peanut or cow’s milk allergies.

The Natasha Clinical Trial, which began in 2023, is a randomised controlled trial – the gold standard in medical research. Before starting the treatment, the children and young people undergo food challenges over two hospital visits to confirm their food allergy diagnosis and make sure they are suitable to have the Oral Immunotherapy Treatment (OIT).

Once enrolled, each patient is given a very small amount of a food to which they are allergic at a dose that is safe for them, which is taken according to a standardised protocol under medical supervision. This may be given either in a hospital clinic or at home with medical support.

An image of the visitors under a sign for the Children's Clinical Research Facility.
The Natasha Allergy Research Foundation (NARF) and their partner organisations came to see first-hand how The Natasha Clinical Trial is helping allergy patients in Leeds.

If they tolerate the food, they then take a daily ‘dose’ of this real food at home, and the amount is gradually increased by the medical team every few weeks while being closely monitored for any adverse effects.

It is hoped that the OIT treatment will mean that patients who had previously suffered anaphylaxis on exposure to products such as peanuts, will now be able to tolerate eating a small amount of the allergen without having a dangerous reaction.  

The study aims to assess the effectiveness of OIT used to train the immune system of children and young people with food allergies to tolerate an allergen. The results and clinical experience gained from the trial will help shape future treatment options for food allergies in the NHS. Results from the trial are expected in 2027.

Visitors from Natasha’s Foundation were given a tour of Leeds Children’s Hospital facilities including the Children’s Allergy Day Unit where patients come for allergy treatments, and the NIHR Leeds Clinical Research Facility Children’s Site where patients come to take part in the study.

The Leeds Children’s Hospital trial is being led by Dr Aida Semic-Jusufagic who said:

‘We’re delighted to welcome visitors from The Natasha Allergy Research Foundation and their supporters today and show them first-hand how their funding is already benefiting our patients here in Leeds. By taking part in this trial, we’re helping to shape the future of the treatment of allergy in the NHS’.   

An image with a Eddie a young patient on the bed with Dr Aida Semic-Jusufagic, sitting at the bed side.
Dr Aida Semic-Jusufagic, lead for the trial, pictured with Eddie a young patient.

The Natasha Clinical Trial is the first major study to be funded by The Natasha Allergy Research Foundation, set up by the parents of Natasha Ednan-Laperouse, who died aged 15 from a severe food allergic reaction.

Visitors spoke to families of patients taking part in The Natasha Clinical Trial in the CRF including parents of 2 year old Iyla who has several food allergies including dairy, egg, nuts, beans and peas. Parents Rachel and Mitesh spoke about how the Iyla’s dietary restrictions affect so many things in her life from child-care and holidays to day-day decisions about where to eat and who to spend time with. Iyla’s parents are delighted she has been given the opportunity to take part in The Natasha Trial.

Visitors from Natasha’s Foundation were joined by representatives from corporate partners Booths, CH&CO, Elior, Greene King and Samworth Brothers.  

Rachel Hodson, Director of Corporate Partnerships and Fundraising at Natasha’s Foundation said:

‘It is great to see first-hand the amazing work going on at Leeds Children’s Hospital and meet some of the participants of The Natasha Clinical Trial and their families. For our partners it was a fantastic opportunity to see how their donations are making a real difference to the lives of people with food allergies.’

NIHR Leeds CRF Lead Nurse Co-Authors Ground-Breaking Stroke Study

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Linetty Makawa

We are delighted to share that Linetty Makawa, Lead Nurse at the NIHR Leeds Clinical Research Facility (CRF), has co-authored a pioneering stroke research paper recently published in the Biomolecules journal.

The study, titled “Rapid Detection of Specific Biomarkers for Differentiation of Stroke Patients from Mimics,” introduces an innovative approach to enhancing the speed and accuracy of stroke diagnosis. Strengthening the partnership between Leeds Teaching Hospitals NHS Trust (LTHT) and the Institute of Cardiovascular and Metabolic Medicine at the University of Leeds (UoL), this research highlights the impact of multidisciplinary collaboration in advancing translational stroke care.

Stroke continues to be one of the leading causes of death and long-term disability worldwide. Early and accurate diagnosis is critical, as treatments are most effective within the first few hours after symptom onset. Yet, distinguishing a true stroke from a “stroke mimic” — a condition with similar symptoms but a different cause — can be difficult, even with advanced imaging and clinical assessments.

In this study, blood samples were analysed from patients with confirmed stroke and from individuals whose symptoms resembled a stroke but were later attributed to other conditions. Researchers identified key blood proteins (biomarkers) associated with brain injury that were present at significantly different levels in stroke patients compared to the mimic group.

The real breakthrough came when researchers combined three of these biomarkers with an existing clinical stroke assessment score. This combination significantly improved the ability to differentiate a genuine stroke from a mimic — paving the way for a rapid, point-of-care blood test that could transform how strokes are diagnosed.

Linetty Makawa, Lead Nurse for the NIHR Leeds CRF, said: “This study brings us closer to using real-time blood tests to support rapid and accurate stroke diagnosis. By integrating key biomarkers with established clinical tools, we can improve the speed and accuracy of assessments and ensure patients receive the right treatment as quickly as possible. Timely diagnosis is crucial—interventions delivered within the first six hours offer the greatest benefit to patients.”

A heartfelt thank you to the lead investigators, Professor Sikha Saha and Professor Kirti Kain (Academic Supervisors, UoL), and to Dr Ahamad Hassan (Clinical Supervisor, LTHT), along with the dedicated team of co-authors: Dr Pragati Kakkar, Dr Meaad Almusined, Dr Tarun Kakkar, and Dr Theresa Munyombwe.

This outstanding achievement not only exemplifies the cutting-edge research taking place here in Leeds but also highlights the leadership, expertise, and innovation within our Clinical Research Delivery. We are incredibly proud of Linetty and the entire team for their contribution to improving stroke diagnosis and care — research that has the potential to make a lasting global impact.

First patient in Europe joins new breast cancer trial in Leeds

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Stock image

The first participant in Europe to take part in a new breast cancer trial has been recruited in Leeds.

The study supported by the NIHR Research Delivery Network, is testing a new drug called BNT327 (also known as PM8002) to see if it’s safe and works well for people with triple-negative breast cancer (TNBC).

TNBC does not have the three common “receptors” found in most breast cancers, the oestrogen, progesterone, and HER2 receptors. Because of this, it has been more difficult to treat because it doesn’t respond to hormone therapies or drugs that target HER2, making it harder to treat. As a result, TNBC is more likely to come back and spread than other breast cancers and patient outcomes are less good.

BNT327 is a special kind of medicine called a “bi-specific antibody”. That means it’s designed to target two specific proteins in and around cancers including TNBC: PD-L1 and VEGF-A.

PD-L1 helps cancer hide from the immune system, and VEGF-A helps tumours grow by creating new blood vessels; BNT327 works by blocking both proteins. BNT327, given with chemotherapy, aims to helps the immune system find and attack the cancer, slows tumours growth by cutting off its blood supply, treating TNBC.

Professor Chris Twelves, University of Leeds, Consultant Medical Oncologist and Director NIHR Leeds Clinical Research Facility CRF) at Leeds Teaching Hospitals NHS Trust is conducting the study with the CRF team at St James’s University Hospital

Professor Chris Twelves, Director of the NIHR Leeds Clinical Research Facility and Trial Lead said :  “There is a particular need for new treatments for people with TNBC so we are especially pleased to be able to offer them this innovative, novel another treatment through this trial” .

The study participant said: “I’m incredibly grateful to the wonderful team running the Leeds trial. Having an additional treatment option has given me renewed hope, and the close monitoring and support of the team have been very reassuring.

Joint Leeds event marks International Clinical Trials Day 2025

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An image of attendees congregating around stalls at the event.

Our teams recently attended the International Clinical Trials Day event jointly organised with and hosted by the NIHR Leeds Biomedical Research Centre.

An image of a staff member with the clinical research facility.

The event recognised the life-changing impact of healthcare research, and the people who make it possible.

We met with researchers, patients and members of the public at the centre for a day of talks, activities and workshops. Visitors heard from researchers about their work, our patient public involvement and engagement team about the work of clinical trials.

An image of a staff member with a stall and brochures

The event showcased an array of cutting-edge research projects, such as managing chronic pain and musculoskeletal conditions, advancing inclusivity for disabled individuals in research, exploring new approaches to treating polymyalgia rheumatica (PMR), and technology in diabetes care.

Attendees also had the opportunity to take part in creative zine-making sessions led by the PMR research team, as well as explore the unit’s imaging facilities during guided tours of the centre’s MRI and ultrasound suites.

A presenter giving a talk to an audience.

This celebration formed part of the National Institute for Health and Care Research (NIHR)’s broader Be Part of Research campaign, which aims to inspire greater public involvement in health and care research. Every breakthrough in treatment begins with participation, whether through clinical trials, research surveys, or other studies. These individual contributions collectively help drive progress in healthcare.

An image of attendees at the event in the garden with yellow flowers in the foreground.

We want to extend our gratitude to everyone who joined the event and contributed to its success, highlighting the invaluable support of the public in shaping the future of medical research.

New immunotherapy trial focusing on older colon cancer patients

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Jenny Seligmann

Individuals with a specific type of tumour will receive an immunotherapy drug called dostarlimab before surgery, rather than the standard procedure where surgery is carried out first, then sometimes followed up by chemotherapy.

This is the first trial to specifically test the outcomes of this approach in older patients with the disease.

FOxTROT 5, led by the University and supported by the NIHR Leeds Clinical Research Facility, heralds a step towards more personalised, precision oncology in colon cancer patients.

People with the disease, who are at least 70 years old, or have significant additional medical conditions, may be able to take part in the trial, which will be running at 20 hospitals across the UK.

It is hoped that the results will inform standard practice, providing evidence of whether this approach could be safe and effective for these types of patients.

The University of Leeds is the trial sponsor, with its Clinical Trials Research Unit (CTRU) leading the study alongside clinicians. The University’s NHS partner site is St James’s University Hospital – Leeds Teaching Hospitals NHS Trust.

The trial will use dostarlimab to target “deficient mismatch repair” (dMMR) colon cancer – a molecularly distinct colon cancer that has been shown in other trials to respond extremely well to immunotherapy. 

Cancer immunotherapies are treatments that use the immune system to find and attack cancer cells. There are several different types and they each use the immune system in a different way and can be administered in various ways.

Addressing health inequality

Professor Jenny Seligmann, Chief Investigator of the FOxTROT programme and Consultant Medical Oncologist at Leeds Teaching Hospitals NHS Trust, said: “This approach has already proved to be good for many younger patients but there’s a lack of evidence for what works for older patients. That’s a significant health inequality, which we hope to address.

“The purpose of FOxTROT 5 is to find an improved treatment for colon cancer patients that have cancer cells with an abnormality called dMMR. Standard chemotherapy treatments can be less successful for these patients.

“We hope this trial will lead to a new treatment for them, as well providing further understanding of the disease for the future.”

The £2.6million project, funded by biopharma company GSK, is being run in collaboration with the University of Glasgow and University of Birmingham. The project is part of the FOxTROT Trial Platform funded by Yorkshire Cancer Research.

Every year, over 44,000 people in the UK are diagnosed with colon cancer and over 16,000 lose their lives because of it.

Patients are usually treated with surgery first and may go on to have chemotherapy afterwards to help prevent the cancer coming back.

However, often old, frail patients aren’t well enough to undergo surgery or necessary anti-cancer treatment afterwards. Delivering an immunotherapy treatment first could prevent that, if this approach is successful.

Most people who develop colon cancer are classed as older or frail, but that group of people isn’t usually eligible for clinical trials, meaning there is little evidence for what works best for them.

FOxTROT 5 is aimed at helping to address that health inequality.

Previous success

The FOxTROT trial platform now has options for most stage 2 and 3 colon cancer patients and has seen great success.

FOxTROT 1, a collaborative study by scientists at Leeds and the University of Birmingham, showed that giving proficient mismatch repair (pMMR) colon cancer patients chemotherapy before, rather than after, surgery reduced the chance of the disease returning within two years by more than a quarter.

The new approach to treating colon cancer has since become a treatment option under NICE (the National Institute for Health and Care Excellence) guidelines.
FOxTROT 2 tests whether the approach works in older, frailer pMMR patients.

FOxTROT 3 is investigating whether more intensive chemotherapy can further improve benefits in pMMR patients who can tolerate it. Both are funded by Yorkshire Cancer Research.
FOxTROT 4 tests targeted oncology treatment in pMMR colon cancer patients with an abnormality in their tumour called a BRAF mutation. These patients currently have particularly poor outcomes.

The launch of FOxTROT 5 means the trial platform now, in theory, offers a trial for all the older and frail stage 2 and 3 colon cancer patients, although some further checks are required for each patient to ensure the trial is suitable for them.

Dr Stuart Griffiths, Director of Research at Yorkshire Cancer Research, said: “The launch of FOxTROT 5 marks a significant development in the FOxTROT Trial Platform and aligns with the charity’s ambition to bring potential benefits from the research to as many people with bowel cancer as possible, in Yorkshire and across the globe. We are grateful to the charity’s supporters for helping to create an important and unique opportunity for Yorkshire to drive forward this exciting research.”

FOxTROT 5 will be launched at 20 hospitals across the UK in the coming months, with the following already offering the trial to patients:

Ninewells Hospital, Dundee

St James’s University Hospital, Leeds

Churchill Hospital, Oxford

Queen’s Hospital Burton

Queen Elizabeth Hospital Birmingham

University Hospital, Coventry

Ipswich Hospital.

To find out more about how you or a family member could take part in FOxTROT 5, please speak to your hospital doctor.

Man becomes first in the world to join new part of brain cancer trial in Leeds

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Ian Johnson and his wife with members of the CRF team

Ian Johnson has become the first person in the world to join a new part of a brain cancer trial testing a drug designed to boost the effects of radiotherapy.

Ian, aged 50, is taking part in a study testing a new drug called AZD1390, which is being used alongside radiotherapy to treat glioblastoma—a type of brain cancer. The drug is designed to make radiotherapy more effective by stopping cancer cells from repairing themselves after treatment.

Glioblastoma is an aggressive type of brain tumour. The usual treatment involves surgery to remove as much of the tumour as possible, followed by radiotherapy and chemotherapy. However, the cancer often returns. The trial is looking for ways to improve treatment for people who have glioblastoma and cancer spread to the brain from elsewhere in the body.

This newly opened part of the trial is led by Professor Susan Short, a Consultant Clinical Oncologist at Leeds Teaching Hospitals.

Ian, a Senior Crown Prosecutor and father of two, was diagnosed with glioblastoma in December 2023 after experiencing symptoms that led to a scan. He said: “The diagnosis was a huge shock; I’d always been healthy and had no medical issues before this.”

He had surgery to remove the tumour in January, followed by radiotherapy and chemotherapy. Unfortunately, a scan showed the tumour had returned. Because his body didn’t respond well to chemotherapy, Ian’s doctor referred him to Leeds to explore other treatment options. That’s when he learned about this trial using AZD1390.

Ian added: “I felt hopeful when I heard about the study. “It gave me another option, and as someone with a degree in biology, I also wanted to help future patients by being part of research.”

Since starting the treatment, Ian says he’s been able to continue doing the things he loves, like walking, birdwatching, and spending time with his family: “Apart from feeling more tired than usual, I haven’t had any major side effects. The team here has been incredible—supportive, kind, and always there to answer questions.

“I would absolutely encourage anyone who’s given the chance to consider a clinical trial. Every new treatment has to be tested, and I feel proud to be helping in that process. It’s given me hope—not just for myself, but for others in the future.” The trial is being carried out at the NIHR Leeds Clinical Research Facility, a dedicated space for testing new treatments safely and carefully with the support of expert staff. Patients also benefit from the state-of-the-art Bexley Wing at St James’s Hospital, which includes a hotel on the top floor for those travelling long distances.

Professor Susan Short, Clinical Oncologist and Neuro Oncologist at Leeds Teaching Hospitals and the University of Leeds said: “We are really pleased to be offering patients access to promising new treatments like AZD1390 here in Leeds. This part of the trial is an important step in improving care for people with brain cancer.”

Leeds Owls young research group contribute to successful paediatrics incubator programme

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An image of Heather Rostron.

Our Leeds Young Research Owls have supported a successful application for the NIHR Incubator programme.

The NIHR Incubator programme provides career development support for researchers in key areas, helping to identify barriers to building research capacity and bringing together communities to develop solutions.

The team behind the successful bid for the General Paediatrics Incubator, led by Dr Katrina Cathie MBE, recognised the importance of input from children and young people. Their contributions were vital in shaping a bid that effectively captured the needs the incubator aims to address.

Dr Cathie met with the Owls last year to explain more about the incubator project and received valuable feedback, which contributed to the success of the bid.

Heather Rostron, Senior Research Nurse and lead for the Owls group said: “Leeds Young Research Owls enjoyed working with Dr Katrina Cathie MBE to help provide ideas for what support the general paediatrics NIHR incubator should be planning to provide for early career researchers in this field. LYRO members and I were thrilled to hear that the bid was successful and we look forward to working with the incubator steering group further in the future.”

The General Paediatrics Incubator will support research into common childhood conditions such as asthma, diarrhoea and vomiting, colds, ear infections, poor growth, and nutrition.

The Incubator programme has already led to several innovative projects, including the Mental Health Research Incubator and the Nursing and Midwifery Incubator.