Plain English Summary
Background and study aims
Gonorrhoea is a sexually transmitted infection (STI) caused by bacteria called Neisseria gonorrhoeae or gonococcus.
The incidence of gonorrhoea is potentially underestimated because it is not always detected. 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. gonorrhoeae 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 their low cost, ease of use and the ability to maintain viability for aerobic, anaerobic and fastidious microorganisms – such as N. gonorrhoeae – 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 incubation and transport system – BioMed’s InTray™ GC – compared to the current method of plating onto a solid growth medium to prepare, transport and detect Neisseria gonorrhoeae in sexual health clinics. Further the objective is 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 gonorrhoeae infection, presence of urethral or vaginal discharge and/or dysuria, or patients with recent medical history and risk factors that in the opinion of the treating clinician warrants investigation for N. gonorrhoeae infection.
What does the study involve?
Participants will be asked to provide a swab sample (vaginal/cervix/rectal swabs for women and urethral/rectal swabs for men) as per normal practice to test for N Gonorrhoea infection.
What are the possible benefits and risks of participating?
Benefits: There is no guaranteed anticipated clinical benefit from taking part in this study. However, if the novel Biomed InTray 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 higher quality of gonorrhoea sampling and testing in the future.
Risks: There is no significant increased personal safety risk anticipated for patients who take part in this study. To obtain sufficient material, patients may be swabbed a second time (using a 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.
Where is the study run from?
Cumbria Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2019 to August 2020
Who is funding the study?
Biomed Diagnostics Inc (USA)
Who is the main contact?
Leon Jonker, leon.jonker@nihr.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Leon Jonker
ORCID ID
Contact details
North Cumbria Integrated Care NHS Foundation Trust
R&D Dept
Carleton Clinic
Carlisle
CA1 3SX
United Kingdom
+44 (0)1228 608926
leon.jonker@nihr.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 41639, IRAS 261500
Study information
Scientific title
A single-centre, prospective evaluative study to investigate the performance of the Bio Med InTray® GC (a sample collection, transport and culture in-vitro device), compared to current standard methods, to microbiologically detect Neisseria gonorrhoeae
Acronym
GONDOLA
Study hypothesis
To determine the microbiological detection rates of gonorrhoea using InTray™ GC liquid transport medium compared to current practice (agar plating) in Cumbrian sexual health clinics.
Ethics approval
Approved 25/04/2019, South East Scotland Research Ethics Committee 01 (Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, UK; +44 (0)131 465 5473; Sandra.Wyllie@nhslothian.scot.nhs.uk), ref: 19/SS/0050
Study design
Non-randomized interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gonococcal infection
Intervention
Participants will be asked to provide a swab sample (vaginal/cervix/rectal swabs for women and urethral/rectal swabs for men) as per normal practice to test for N gonorrhoeae 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 - may be taken if the initial swab is insufficient.
The swab(s) are used to inoculate a standard agar plate and a Biomed InTray™ plate, and these will be processed after transport to the microbiology laboratory for diagnostic testing. Thereafter the patient 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. One difference is that the results of both the agar plating and Biomed InTray™ system may be used to manage patients, subject to agreement from the microbiologist and sexual health consultant. This means that if the Biomed InTray system performs better than agar plating, more gonorrhoea cases may be detected and treated accordingly.
There are no follow-up visits when patients take part in the study - it is just a single visit (ie the clinic visit that patients already attend).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Detection rates of gonococcal infection assessed by microbiology laboratory diagnostic testing
Secondary outcome measures
None
Overall trial start date
19/03/2019
Overall trial end date
31/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presenting to sexual health clinic with symptom(s) of Neisseria gonorrhoeae infection, presence of urethral or vaginal discharge and/or dysuria OR
2. Recent medical history and risk factors that in the opinion of the treating clinician warrants investigation for N. gonorrhoeae infection
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
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
29/04/2019
Recruitment end date
31/08/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Carleton Clinic
Cumbria Partnership NHS Foundation Trust
Cumwhinton Road
Carlisle
CA1 3SX
United Kingdom
Sponsor information
Organisation
North Cumbria University Hospitals NHS Trust
Sponsor details
(now known as North Cumbria Integrated Care NHS Foundation Trust)
Voreda House
Portland Place
Penrith
Carlisle
CA11 7BF
United Kingdom
+44 (0)1228 608926
dave.dagnan@ncic.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Biomed Diagnostics Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
31/03/2021
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN16307168_PROTOCOL_v4_6Dec2019.pdf uploaded 05/03/2020