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#TALK Research - Middlemore Clinical Trials Newsletter

Dec 21, 2022

Welcome to the December Edition of #TALK.Research

Kia Ora Koutou,

Welcome to the last edition of #Talk Research for 2022.

We would like to share with you our plans to change the name of Middlemore Clinical Trials. Yes, from 1st January 2023 we will be known as Aotearoa Clinical Trials.

So why the change? The new name we feel reflects three things:

To be responsive to the new changes to the health system and the creation of Te Whatu Ora – Health New Zealand. We see the opportunity to create collaborative groups of clinicians and research staff in specific therapeutic areas across multiple hospital sites that are offered the same clinical protocol, on the same terms, with the same support in place. We think this will grow the clinical trial programs in NZ, encouraging more sponsors to bring their trials here.
The desire to extend what we offer to other hospitals and communities throughout New Zealand.
Be more reflective of all the communities we serve.

However, at no time will we forget our roots here at Counties Manukau and Middlemore Hospital. We will always want to have a significant presence here and we are very grateful to be able to partner with people and departments who are as passionate about research and clinical trials as we are.

2023 looks like an exciting year with more research opportunities and clinical trial programs than ever before. We certainly look forward to working with you in 2023.

Meri Kirihimete to you all and best wishes for the festive season.

Dr Ed Watson
CEO

A Bit of Fun Along the Way

MMCT once again took part in the Goodman Fun Run & Walk at Highbrook park. Proceeds from the event go to and support our local charities including the Middlemore Foundation and Kidz First. Well done to everyone who took part, especially Anastasia Andreianova (2nd from right) who came 3rd in the women’s 5km run and 10th overall.

Happy Holidays from the Middlemore Clinical Trials Team

What's In This Issue:

Grant-Funded Research at MMCT
Meet the Team - Dr Nicola Jackson, PhD (Grants Manager)
Recent Publications by CMH Investigators
Trials Starting at MMCT and Trial Statistics

Grant-Funded Research at MMCT

With 2022 coming to an end, it’s time to celebrate grant-funded research at MMCT. Approximately 43% of MMCT’s portfolio is grant-funded research of which there are two types:

COLLABORATIVE GROUP TRIALS	INVESTIGATOR INITIATED TRIALS
Investigators work together on a trial based regionally, nationally, or internationally	Investigator develops a protocol for their research idea and seeks their own funding

The grants team assist with all aspects of running a clinical trial from looking for funding opportunities to publication and communication of trial results. From an operational perspective, grant-funded research and commercial trials are quite similar. However, the set-up of grant-funded research can be far more intensive, requiring significant efforts by the team to get these trials up and running. The result? A great investment in seeing them succeed.

Grant-funded research does not always involve trialling a new therapy. The Emergency Department currently has six ongoing trials all of which are grant-funded. These trials are either observational studies gathering data to guide or improve standard of care, or interventional studies comparing standard of care with an altered regimen or a different but known therapy. Three of these studies received funding and started recruitment this year. Dr Eunicia Tan has been instrumental in increasing research in the department and is the Principal Investigator for all but one of the six studies.

Current grant-funded studies in the Emergency Department:

OBSERVATIONAL	INTERVENTIONAL
ED Safety – Rate of adverse events following a visit to the ED	BIPED – Epinephrine versus dexamethasone to treat bronchiolitis in infants
CRANIAC – Concussion recovery in adolescents and children	PRoMPT Bolus – Balanced fluid versus normal saline resuscitation to decrease kidney injury in children with septic shock
SONIC – Clinical decision rules for children with suspected cervical spine injuries	Arise Fluids – Restricted fluids and early introduction of vasopressors for haemodynamic resuscitation of patients with septic shock

Dr Genevieve Walls leads the New Zealand arm of the study SNAP, the Staphylococcus aureus Network Adaptive Platform Trial. This is a multi-centre randomised adaptive platform clinical trial comparing standard of care treatments for Staphylococcus aureus (S. aureus) bloodstream infections. New Zealand has one of the highest annual incidence of S. aureus bloodstream infections in the world. Since the first sites opened in February 2022, the study has recruited 300 participants worldwide with a further 414 enrolled in the SNAP SAB (Staphyloccocus aureus bacteremia) registry. SNAP currently has 4 active sites in NZ, who have together contributed 84 enrolments to the main study and 106 to the registry. We expect a further 6 sites to open early in 2023, with the New Zealand arm of the study aiming to recruit 1100 participants over the next 3 years. Earlier this year, the paediatric arm of SNAP, named SNAP-PY (Staphylococcus aureus Network Adaptive Platform Trial – Paediatric and Youth), led by Dr Rachel Webb also began recruiting at Starship Children’s hospital and aims to recruit approximately 180 participants aged 16 years and under. Kidz First at Middlemore Hospital will also come on board as a SNAP-PY site in 2023.

The Adolescent Bariatric Surgery Study, led by Dr Brandon Orr-Walker, consented their final participant late this year reaching their recruitment target of 20 participants. Counties Manukau Health has a disproportionately high prevalence of morbidly obese people, including children and adolescents, compared to other regions of New Zealand. The aim of this pilot study is to evaluate the benefit of intensive lifestyle interventions (low-calorie diet, exercise) with or without bariatric surgery in morbidly obese adolescents with or without type 2 diabetes. It is hypothesised that adolescents receiving a lifestyle intervention and bariatric surgery will have a lower incidence of pre-diabetes, type 2 diabetes, and other related comorbidities such as impaired renal function, fatty liver, obstructive sleep apnoea and secondary amenorrhea. Enrolment for this study began in early 2020 and was a challenge due to the COVID pandemic and difficultly accessing the target population.

Meet the Team
- Dr Nicola Jackson (Grants Manager)

It is with pleasure that we announce the appointment of Dr Nicola Jackson PhD to the position of Grants Manager.

Nicola has extensive biomedical research experience having worked in both academic and commercial settings in the UK and NZ. She is very familiar with writing and applying for research grants, critiquing scientific writing and communicating research science.

Nicola looks forward to continuing to expand the grants portfolio at MMCT. Please join us in welcoming Nicola to this role.

Recent Publications by CMH Investigators

Davis W, Duque J, Huang QS, Olson N, Grant CC, Newbern EC, Thompson M, Waite B, Prasad N, Trenholme A, Azziz-Baumgartner E. Sensitivity and specificity of surveillance case definitions in detection of influenza and respiratory syncytial virus among hospitalized patients, New Zealand, 2012-2016. J Infect. 2022 Feb;84(2):216-226. doi: 10.1016/j.jinf.2021.12.012. Epub 2021 Dec 22. PMID: 34953903.

Gelbart B, McSharry B, Delzoppo C, Erickson S, Lee K, Butt W, Rea M, Wang X, Beca J, Kazemi A, Shann F. Pragmatic Randomized Trial of Corticosteroids and Inhaled Epinephrine for Bronchiolitis in Children in Intensive Care. J Pediatr. 2022 May;244:17-23.e1. doi: 10.1016/j.jpeds.2022.01.031. Epub 2022 Jan 31. PMID: 35093318.

Goh MF, Hollewand CE, McBride S, Mathy JA. Microbiology of surgical site infections (SSIs) following skin cancer surgery. ANZ J Surg. 2022 Sep;92(9):2269-2273. doi: 10.1111/ans.17957. Epub 2022 Aug 1. PMID: 35912956.

Hernández-Mitre MP, Tong SYC, Denholm JT, Dore GJ, Bowen AC, Lewin SR, Venkatesh B, Hills TE, McQuilten Z, Paterson DL, Morpeth SC, Roberts JA. Nafamostat Mesylate for Treatment of COVID-19 in Hospitalised Patients: A Structured, Narrative Review. Clin Pharmacokinet. 2022 Oct;61(10):1331-1343. doi: 10.1007/s40262-022-01170-x. Epub 2022 Aug 30. PMID: 36040613; PMCID: PMC9425784.

Kayes T, Crane H, Symonds A, Dumond J, Cottrell M, Di Girolamo J, Manandhar S, Lim TH, Gane E, Kashuba A, Levy MT. Plasma and breast milk pharmacokinetics of tenofovir alafenamide in mothers with chronic hepatitis B infection. Aliment Pharmacol Ther. 2022 Aug;56(3):510-518. doi: 10.1111/apt.17040. Epub 2022 May 22. PMID: 35599363.

McQuilten ZK, Venkatesh B, Jha V, Roberts J, Morpeth SC, Totterdell JA, McPhee GM, Abraham J, Bam N, Bandara M, Bangi AK, Barina LA, Basnet BK, Bhally H, Bhusal KR, Bogati U, Bowen AC, Burke AJ, Christopher DJ, . . . Tong SYC (2022). Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19. NEJM Evidence. doi: 10.1056/EVIDoa2200293

Tan E, Beck S, Haskell L, MacLean A, Rogan A, Than M, Venning B, White C, Yates K, McKinlay CJ, Dalziel SR. Paediatric fever management practices and antipyretic use among doctors and nurses in New Zealand emergency departments. Emerg Med Australas. 2022 Dec;34(6):943-953. doi: 10.1111/1742-6723.14022. Epub 2022 May 29. PMID: 35644989.

Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. J Hepatol. 2022 Nov;77(5):1287-1298. doi: 10.1016/j.jhep.2022.07.010. Epub 2022 Jul 20. PMID: 35870702.

Interested In Applying For Funding?

A range of funding opportunities are available for research projects. If you are interested in applying or not sure which grant is right for you, please email the Grants Team

Contact the Grants Team

Trials Starting at MMCT

List of upcoming trials that are planned to start recruitment in the next three months:

To learn more about the trials we are performing at Middlemore Hospital, please visit our website and see what trials in what disease areas we are currently working on.

Together through research we can improve the lives of many of the patients in Counties Manukau.

View Current Recruiting Trials

MMCT Contacts

Type of Enquiry	Person	Email Address
Feasibilities	Kate Msiska	feasibility@middlemoretrials.nz
Trial Contracts	Kate Msiska	contracts@m iddlemoretrials.nz
Finance	Emani Setefano	finance@middlemoretrials.nz
Investigator Initiated/Grant Funded Trials	Dr Nicola Jackson Dr Hannah Burden	grants @mi ddlemoretrials.nz
Regulatory/Ethics	Catherine Howie	ethics@mi ddlemoretrials.nz
For support when a clinically significant event occurs with a trial	Dr John Baker	John.Baker@mi ddlemoretrials.nz
To refer a patient for a clinical trial	Please visit our website	Recruiting Trials participants @mi ddlemoretrials.nz