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Dr Fiona McGill

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Whole team

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FOST Switch (PI - Dr Harriet Wallace)

Evaluating Efficacy and Safety of Switching a Boosted Protease Inhibitor to Fostemsavir in PLWH with Limited Therapeutic Options

Current Status: awaiting OneForm KSS approvals.

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Dr Sarah Schoeman

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Showna Benjamin

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Dr Adam Burns

Dr Penny Lewthwaite (on leave)

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SNAP (PI - Dr Fiona McGill):
Study is trying to identify the effect of a range of clinical interventions on all-cause 90-day mortality in patients with Staphylococcus aureus bacteraemia (SAB) which hopefully will lead to improved treatment outcomes.

Current Status: awaiting the greenlight from R&I and the sponsor.

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ISARIC (Monkeypox):
The ISARIC-WHO Clinical Characterisation Protocol has been activated in the UK and an updated case report form has been shared with ISARIC Partners in other countries for implementation.

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8 February 2024: A new study finds that children hospitalised with initial COVID-19 variant showed more signs of dermatological, fatigue, gastrointestinal, sensory, and sleep issues, as well as behavioural and emotional problems.

15 January 2024: In a new paper published in The Lancet Infectious Diseases, researchers based in Bangladesh, Oxford and Geneva call for a comprehensive public health framework to counter Nipah virus and other neglected infectious diseases with pandemic potential.

18 December 2023: The International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) is working with partners to create a framework on endpoint selection for clinical trials for outbreak-prone infectious diseases. This call for a public consultation invites feedback on what the framework does well, what could be improved and the limits of its potential application.

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International Severe Acute Respiratory and emerging Infection Consortium

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International Severe Acute Respiratory and emerging Infection Consortium. Our purpose is to prevent illness and deaths from infectious disease outbreaks.

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Dr Fiona McGill

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Dr Sarah Schoeman

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Dr Fiona McGill

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Dr Jonathan Sandoe

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Not Applicable

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Senior Research Nurse:

Claire Reidy

claire.reidy@nhs.net

Research Nurse:

Honorine Jobain

honorine.jobain@nhs.net

Clinical Research Practitioner:

Tadas Mazeika

tadas.mazeika@nhs.net

Clinical Research Practitioner:

Kiran Chana

kiran.chana@nhs.net

Research Practitioner:

Claire Forrest

claireforrest@nhs.net

Senior Clinical Trials Assistant:

Showna Benjamin

showna.benjamin@nhs.net

For any general enquiries:

leedsth-tr.infectionresearch@nhs.net
0113 20 66083

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Spot Available

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Dr Fiona McGill

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The Associate Principal Investigator Scheme aims to develop health and care professionals to become the Principal Investigators (PIs) of the future.

What is it?
A 6 month in-work training opportunity to gain practical experience within healthcare research

Why?
Personal development
Formal recognition of engagement in NIHR Portfolio research

Who?
Any healthcare professional who would like to get involved in research

How?
Contact our study team to find out more about current studies we are running with the associate PI scheme in place!

More information about the scheme can be found here.

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We would be really grateful for interest from any of the ED consultants in becoming a Principal Investigator (PI) on either of our potential studies.

If you have never been a PI, please do not let that deter you! We will provide full support and it is a really interesting addition to ones overall portfolio.

For more information please contact us.

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Not Applicable

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Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP assures patients and the public that the rights, safety and well-being of people taking part in studies are protected and that research data is reliable.

Free GCP training course for people supporting clinical research delivery at the NHS, UK universities and other publicly funded organisations in England is available here.

First time learner:
- GCP eLearning (May 2022) course.

Refresher (every 2 years):
- GCP Refresher eLearning (May 2022) course.

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Honorine Jobain

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Not applicable

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Not applicable

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Not Applicable

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Infection & Emergency Medicine Research
Level 8, Gledhow Wing,
St James's University Hospital,
Leeds LS9 7TF

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Honorine Jobain

Showna Benjamin

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PRONTO is a randomised controlled trial looking to compare PCT supported assessment with standard care of suspected sepsis in adults presenting to the ED, and measure whether this approach reduces prescriptions of antibiotics without increasing mortality by decreasing uncertainty in the group who may not need IV antibiotics urgently within 1 hour, or not need antibiotics at all.

Website: PRONTO

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PROcalcitonin and NEWS2 evaluation for Timely identification of sepsis and Optimal use of antibiotics in the Emergency Department.

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Honorine Jobain

Claire Forrest

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Honorine Jobain

Claire Forrest

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Tadas Mazeika

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DexEnceph Research Protocol V 4.0 14 09 2022 clean

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DexEnceph study consists of a RCT which will assess and compare the outcomes of patients with HSV encephalitis randomised to receive dexamethasone or not. Patients will be randomised at the time of diagnosis of HSV encephalitis but they can be identified earlier and prospectively consented prior to laboratory confirmation of HSV in the CSF. This is an observer blind, open label, prospective, randomised controlled trial of dexamethasone fixed dosing of 10mg 6 hourly for 4 days versus no dexamethasone in adult patients with HSV encephalitis.

The project also has a Non-HSV Cohort Study that aims to compare the disease processes and pathological mechanisms of HSV encephalitis to those who do not have HSV encephalitis but present to hospital with similar symptoms.

Website: DexEnceph

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DexEnceph: A study of dexamethasone in adults with Herpes Simplex Virus (HSV) encephalitis

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DexEnceph: A study of dexamethasone in adults with Herpes Simplex Virus (HSV) encephalitis

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PRONTO Consent Flowchart for Site Staff v2.0 07.06.22 FINAL

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ALABAMA study looks at penicillin allergy status and its effect on antimicrobial prescribing, patient outcomes, and antimicrobial resistance. The main aim is to find out if people with a penicillin-allergy label in their GP health records really do have an allergy by specialist testing, and to see if we can reduce the number of patients wrongly labelled as penicillin allergic.

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The main purpose of LAPTOP study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

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The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.

The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:

The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®.

The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®.

The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.

In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.

To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.

The effectiveness of HIV antiretroviral therapy (ART) has consistently improved over the years. This is largely due to newer drugs having improved antiviral effectiveness and more tolerable side effect profiles; resulting in better viral suppression and improved treatment adherence. On the other hand, most recent clinical trials look at the effectiveness of ART in patients with less advanced disease. These patients usually suffer from less related diseases, drug-drug interactions, and other risks for treatment failure. Outside of these trials, the number of patients who present to clinic with a more developed advanced HIV infection, known as 'late presenters', remains high across Europe. Trials for these patients have tended to focus on the time of starting treatment and the management of infections.

Much less is known about which ART treatments perform best for these late presenting patients; particularly in terms of virus suppression, immune system recovery, side effects and improvement of AIDs related diseases. No specific drug combinations have been compared in appropriate clinical trials before, and the international guidelines for first line treatment judge all therapies as equal standard of care for these patients.

The investigators anticipate that Integrase inhibitor containing regimes may be better suited to patients with advanced disease, due to their beneficial side-effect profile and ability to rapidly decrease viral load levels. Therefore the investigators are conducting this clinical trial to compare an integrase inhibitor regime, against a protease inhibitor regime in patients with advanced HIV infection. The aim of the study is to demonstrate the non-inferiority of Biktarvy® against Symtuza®.

Patients will be recruited from sites across Europe, and randomized onto either arm of the study. After randomisation onto either treatment regime, patients will attend approximately 9 follow-up visits over the course of a year. During these visits, patients will be asked to complete two questionnaires, to assess their quality of life and HIV symptoms. They will also be asked to provide a number of blood samples. These samples are to ensure that the patient is not resistant to the study drug and that their disease is not worsening. Samples to test for study drug resistance will be shipped to a laboratory for analysis in the even that the patient experiences virological failure.

Biktarvy® will be supplied from Gilead and Symtuza® will be provided by Janssen Pharmaceuticals.

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The Late Presenter Treatment Optimisation Study - Full Text View - ClinicalTrials.gov

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The Late Presenter Treatment Optimisation Study - Full Text View.

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TB-DILI aim is to identify the safest and most effective way to restart treatment for patients that have had their TB treatment stopped due to experiencing drug-induced liver injury (DILI).

Website: TB-DILI Website

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What is the TB-DILI study?

The aim of the TB-DILI study is to identify the safest and most effective way to restart treatment for patients that have had their TB treatment stopped due to experiencing drug-induced liver injury (DILI).

We will also determine which re-introduction strategy is most cost-effective for the NHS. It is entirely your decision whether to take part in this study. If you agree to take part, you are free to withdraw at any time without giving a reason. If you choose not to take part, your care will not be affected

Who is organising and funding this study?

The study is being organised by the Nottingham University Hospitals NHS Trust (the Sponsor) and coordinated by the Nottingham Clinical Trials Unit (NCTU). The funding for the study is provided by the National Institute for Health Research (NIHR).

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by North East - Tyne and Wear South Research Ethics Committee.

Patients who have previously been treated for TB have helped us plan and design this study. Patients' representatives are also involved in the teams that oversee the running of the study.

TB-DILI Twitter

Follow us on Twitter!

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The aim of the TB-DILI study is to identify the safest and most effective way to restart treatment for patients that have had their TB treatment stopped due to experiencing drug-induced liver injury (DILI). We will also determine which re-introduction strategy is most cost-effective for the NHS.

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The iHOST study seeks to address this gap by implementing a five-pronged intervention to improve OST provision in acute hospital settings. The intervention has been co-developed with people who use opioids and other key stakeholders.

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Improving Hospital Opioid Substitution Therapy | LSHTM

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Improving Hospital Opioid Substitution Therapy (iHOST): implementation and assessment of an intervention to reduce late presentations, discharges against medical advice and repeat admissions among people who use opioids.