Storage, transport and incubation for N. gonorrhoea samples

ISRCTN ISRCTN55795067
DOI https://doi.org/10.1186/ISRCTN55795067
IRAS number 243037
Secondary identifying numbers CPMS 40245, IRAS 243037
Submission date
03/02/2020
Registration date
11/03/2020
Last edited
07/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Leon Jonker
Scientific

Cumbria Partnership NHS Foundation Trust
R&D Dept, Carleton Clinic
Carlisle
CA1 3SX
United Kingdom

Phone +44 (0)1228608926
Email leon.jonker@nihr.ac.uk

Study information

Study designNon-randomised; Interventional; Design type: Diagnosis, Device
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeDiagnostic
Participant information sheet ISRCTN55795067_PIS_v2_01Oct19.docx
Scientific titleA 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
Study acronymSTRINGS
Study objectivesThis 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(s)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
Health condition(s) or problem(s) studiedNeisseria gonorrhoea infection
InterventionIf 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 typeOther
Primary outcome measureThe 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 measuresMeasured 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 study start date01/10/2018
Completion date30/05/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 64; UK Sample Size: 64
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2018
Date of final enrolment30/04/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

North Cumbria Integrated Care NHS Foundation Trust
Hospital/treatment centre

c/o Dave Dagnan
Carleton Clinic, R&D Dept
Carlisle
CA1 3SX
England
United Kingdom

Phone +44 (0)1228608926
Email dave.dagnan@cumbria.nhs.uk
Website https://www.ncic.nhs.uk/
ROR logo "ROR" https://ror.org/003hq9m95

Funders

Funder type

Industry

Medical Wire & Equipment Co. (Bath) Limited

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination plan1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version v2 01/10/2019 11/03/2020 No Yes
Protocol file version v2 01/03/2019 11/03/2020 No No
HRA research summary 26/07/2023 No No

Additional files

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

Editorial Notes

07/06/2023: Internal review.
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.