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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Martina Furegato
mfuregat@sgul.ac.uk


Dr Tariq Sadiq
ssadiq@sgul.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Precise Study: NG & MG point-of-care test evaluation

Precise Study: NG & MG point-of-care test evaluation

Completed

Open to: Female / Male

Age: 16 Years - N/A

Medical Conditions

Infections with a predominantly sexual mode of transmission


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Testing for sexually transmitted infections (STIs) enables diagnosis and appropriate clinical management of individuals, thus preventing serious health consequences. It is an important public health intervention with potential to reduce onward transmission of infection to sexual partners, and reducing the emergence of antimicrobial resistance (AMR). New technologies, including point of care tests (POCTs), especially those that combine detection of the pathogen and AMR, may help overcome challenges of STI prevention by enabling immediate diagnosis and appropriate treatment, improving partner notification, quality of patient care and antibiotic stewardship.

Through a three-year NIHR i4i-funded grant (II-LB-0214-20005), the team at St George’s University of London have been working with Atlas Genetics, to develop a POCT for diagnosis and AMR for the two STIs Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG). We are now able to conduct a prospective diagnostic accuracy study of the test using patient-consented (additional to routine) clinical samples, to evaluate the Atlas io platforms and its associated cartridges. For NG, the primary outcome is to set the detection level whereby samples are considered negative and assess the test’s utility as a reflex test for patients already diagnosed with NG. For MG, we will look at the accuracy of detection and AMR. Secondary outcomes are an epidemiological description of the recruited population, and modelling clinical impact of POCTs.

We will work with Atlas Genetics and a number of UK NHS Genitourinary Medicine (GUM) clinics, over 12 months. Following informed consent, females will be asked to provide 2 additional vulvo-vaginal swabs, males an additional portion of first void urine, and men-who-have-sex-with men (MSM) two additional pharyngeal and rectal swabs. The results of the tests will not be used to inform patient care. Participants will only be recruited during one routine clinical visit, no follow up is required.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 May 2017 30 Jun 2018

Observational

Observational type: Cross-sectional;



You can take part if:



You may not be able to take part if:


Patients that do not meet all of inclusion criteria will not be eligible.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Dr Tariq Sadiq
ssadiq@sgul.ac.uk


Martina Furegato
mfuregat@sgul.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by St. George's Hospital Medical School and funded by NIHR Central Commissioning Facility (CCF) .




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for Trial ID: CPMS 33444

Last updated 16 October 2020

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