Plain English Summary
Background and study aims
The incidence of gonorrhoea is potentially underestimated because of suboptimal processing of samples, diagnosis methodology, case reporting and surveillance. Undetected or inadequately treated Gonorrhoea can cause serious reproductive health consequences and poses a threat to public health due to the emergence of drug-resistant strains; timely and accurate diagnosis is therefore essential. Despite high specificity tests available, N. gonorrhoea bacteria are technically difficult to preserve and recover from clinical specimens. Any delay in processing, transport and incubation of direct culture plates can significantly reduce the sensitivity of the test, resulting in false-negative results and non-treatment. Novel swab transport systems have become increasingly important due to their low cost, ease of use and the ability to maintain viability for aerobic, anaerobic and fastidious microorganisms – such as N. gonorrhoea – over extended times. This may have benefits in clinic settings across the UK, particularly in rural settings where transport times to laboratories may be longer. This study aims to assess the performance of a novel swab transport system – Sigma VCM (product code MW911S, marketed by the company MWE) – compared to the current method of plating onto a solid growth medium to prepare, transport and detect Neisseria gonorrhoea in sexual health clinics, and to assess the potential cost-effectiveness and benefits in terms of storage, transport and incubation time
Who can participate?
Patients presenting to sexual health clinic with symptom(s) of Neisseria gonorrhoea
What does the study involve?
Participants will be asked to provide a swab sample (vaginal/cervix swabs for women and a urethral sample for men) as per normal practice to test for N. gonorrhoea infection. The samples will be processed using the current standard method (which is to use so-called solid agar incubation plates). As part of the study, an additional swab sample - from the same location and using the same type of swab - will be taken and this will be processed using a tube with liquid in it to transport the sample to the laboratory for diagnostic testing. Thereafter participants will be cared for in the same matter as they normally would. The results of the tests will be communicated as per normal practice by the clinical team. There are no follow-up visits when patients take part in the study - it is just a single visit (i.e. the clinic visit that patients already attend).
What are the possible benefits and risks of participating?
There is no intended clinical benefit from taking part in this study. However, if the novel Sigma VCM shows significant benefits over the current practice, meaning higher detection rates of Gonorrhoea, then the clinical team can use these results for the management of patients. This means that patients may be treated more optimally if the new sample transport kit that is being tested outperforms the current standard transport method. As a result, this study may then also lead to a higher quality of gonorrhoea sampling and testing in the future. This is not guaranteed, and that is why the researchers are undertaking this study to determine which transport process for sexual health samples is best. Participants cannot claim payments, reimbursement of expenses or any other benefits or incentives for taking part in this study. There is no significant increased personal safety risk anticipated for participants. To obtain sufficient material, patients may be swabbed a second time (using the same type of swab they would normally be swabbed with). This may feel a bit uncomfortable for a very brief period of a few seconds. Appropriate precautions are in place to ensure that medical and personal information is kept safe.
Where is the study run from?
North Cumbria Integrated Care NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2018 to May 2020
Who is funding the study?
Medical Wire & Equipment Co. (Bath) Limited
Who is the main contact?
Dr Leon Jonker
leon.jonker@nihr.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Leon Jonker
ORCID ID
Contact details
Cumbria Partnership NHS Foundation Trust
R&D Dept
Carleton Clinic
Carlisle
CA1 3SX
United Kingdom
+44 (0)1228608926
leon.jonker@nihr.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 40245, IRAS 243037
Study information
Scientific title
A single-centre, controlled, prospective study to investigate the performance of the novel Sigma VCM diagnostic storage and transport kit compared to current standard methods to detect Neisseria gonorrhoea
Acronym
STRINGS
Study hypothesis
This study aims to assess the performance of a novel swab transport system – Sigma VCM (product code MW911S, marketed by the company MWE) – compared to the current method of plating onto a solid growth medium to prepare, transport and detect Neisseria gonorrhoea in sexual health clinics and to assess the potential cost-effectiveness and benefits in terms of storage, transport and incubation time.
Ethics approval
Approved 30/10/2018, London - Dulwich Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8241, +44 (0)2071048089; dulwich.rec@hra.nhs.uk), REC ref: 18/LO/1936
Study design
Non-randomised; Interventional; Design type: Diagnosis, Device
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Neisseria gonorrhoea infection
Intervention
If a patient decides to take part in the study, written informed consent will be taken.
Participants will be asked to provide a swab sample (vaginal/cervix swabs for women and a urethral sample for men) as per normal practice to test for N. gonorrhoea infection. The samples will be processed using the current standard method (which is to use so-called solid agar incubation plates).
As part of the study, an additional swab sample - from the same location and using the same type of swab - will be taken and this will be processed using a tube with liquid in it to transport the sample to the laboratory for diagnostic testing. Thereafter participants will be cared for in the same matter as they normally would. The results of the tests will be communicated as per normal practice by the clinical team.
There are no follow-up visits when patients take part in the study - it is just a single visit (i.e. the clinic visit that patients already attend).
Intervention type
Other
Phase
Drug names
Primary outcome measure
The detection rates of the Sigma VCM compared to current (in)direct agar plating practise in Cumbrian sexual health clinics, measured using NAAT (PCR) at a single study visit
Secondary outcome measures
Measured at a single timepoint/study visit:
1. The detection rates of direct or indirect plating versus Sigma VCM, measured using NAAT (PCR) at a single study visit
2. Time between sample taken from patient to arrival in the microbiology department, measured using timing records in patient and laboratory records
3. Storage requirements, measured using feedback from clinical staff
4. Transport requirements, measured using feedback from clinical and laboratory staff
5. Incubation time, measured using laboratory records
6. Costs (including materials), measured using cost utilisation analysis
Overall trial start date
01/10/2018
Overall trial end date
30/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presenting to sexual health clinic with symptom(s) of Neisseria gonorrhoea
2.1. Presence of urethral or vaginal discharge and/or dysuria
OR
2.2. Recent medical history and risk factors that in the opinion of the treating clinician warrants investigation for N. gonorrhoea infection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 64; UK Sample Size: 64
Participant exclusion criteria
1. Under the age of 18 years
2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
Recruitment start date
01/12/2018
Recruitment end date
30/04/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cumbria Partnership NHS Foundation Trust
Carleton Clinic
Cumwhinton Road
Carlisle
CA1 3SX
United Kingdom
Sponsor information
Organisation
North Cumbria Integrated Care NHS Foundation Trust
Sponsor details
c/o Dave Dagnan
Carleton Clinic
R&D Dept
Carlisle
CA1 3SX
United Kingdom
+44 (0)1228608926
dave.dagnan@cumbria.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Medical Wire & Equipment Co. (Bath) Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN55795067_PROTOCOL_v2_01Mar19.docx Uploaded 11/03/2020
- ISRCTN55795067_PIS_v2_01Oct19.docx Uploaded 11/03/2020