GONDOLA: Gonorrhoea detection using laboratory assessment

ISRCTN ISRCTN16307168
DOI https://doi.org/10.1186/ISRCTN16307168
IRAS number 261500
Secondary identifying numbers CPMS 41639, IRAS 261500
Submission date
03/02/2020
Registration date
05/03/2020
Last edited
05/03/2020
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
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

Contact information

Dr Leon Jonker
Scientific

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

Phone +44 (0)1228 608926
Email leon.jonker@nihr.ac.uk

Study information

Study designNon-randomized interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study acronymGONDOLA
Study objectivesTo 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(s)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
Health condition(s) or problem(s) studiedGonococcal infection
InterventionParticipants 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 typeProcedure/Surgery
Primary outcome measureDetection rates of gonococcal infection assessed by microbiology laboratory diagnostic testing
Secondary outcome measuresNone
Overall study start date19/03/2019
Completion date31/08/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 60; UK Sample Size: 60
Key inclusion criteria1. 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
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 enrolment29/04/2019
Date of final enrolment31/08/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

North Cumbria University Hospitals NHS Trust
Hospital/treatment centre

(now known as North Cumbria Integrated Care NHS Foundation Trust)
Voreda House
Portland Place
Penrith
Carlisle
CA11 7BF
England
United Kingdom

Phone +44 (0)1228 608926
Email dave.dagnan@ncic.nhs.uk

Funders

Funder type

Industry

Biomed Diagnostics Inc

No information available

Results and Publications

Intention to publish date31/03/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version v4 06/12/2019 05/03/2020 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN16307168_PROTOCOL_v4_6Dec2019.pdf
uploaded 05/03/2020

Editorial Notes

05/03/2020: Uploaded protocol (not peer reviewed) as an additional file.
03/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).