Storage, transport and incubation for N. gonorrhoea samples

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

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

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 40245, IRAS 243037

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)

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

Countries of recruitment

United Kingdom

Trial participating centre

Cumbria Partnership NHS Foundation Trust
Carleton Clinic Cumwhinton Road
Carlisle
CA1 3SX
United Kingdom

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

Funder type

Industry

Funder name

Medical Wire & Equipment Co. (Bath) Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

• ISRCTN55795067_PROTOCOL_v2_01Mar19.docx Uploaded 11/03/2020
• ISRCTN55795067_PIS_v2_01Oct19.docx Uploaded 11/03/2020

11/03/2020: Uploaded protocol Version 2, 1 March 2019 (not peer reviewed). The participant information sheet has been uploaded. 03/02/2020: Trial's existence confirmed by the NIHR.