Sexually Transmitted Diseases, BacterialGuardianNCT05391035
The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.
An observational study of Sexually Transmitted Diseases, Bacterial and Antibiotic Resistant Infection, run by Cwm Taf University Health Board (NHS) at 2 sites in United Kingdom.
Trial summary
Primary research question: Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic? Secondary research question: Are novel molecular tests for detection of antimicrobial resistance… Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Sexually Transmitted Diseases, Bacterial, Antibiotic Resistant Infection
- How many people
- 160 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2019to 17 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Symptomatic patients attending a sexual health clinic in Cwm Taf Morgannwg health board, UK.
Who may be able to join
- Patients that are sexually active.
- Patients that are symptomatic with:
- Dysuria
- Urethral discharge
- Vaginal discharge
- Rectal discharge
Show all 11Show fewer
- Dysparenia (pain during sex)
- Pelvic pain
- Testicular pain
- Post-coital bleeding (bleeding after sex)
- Vulval/Glans/Perianal pain.
Who cannot join
- Pregnancy.
- Aged under 16 years.
- Sexual assault case.
- Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
- Patients lacking capacity to consent.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cwm Taf Morgannwg University Health board
Llantrisant, Rhondda Cynon Taf, CF82 7XR
Lucy Jones
Pontypridd, CF37 1LB
About this study
Official title: The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.
Primary research question:
Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic?
Secondary research question:
Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?
Read the detailed description
This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail.
Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic.
Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques.
Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic.
Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID.
Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic.
This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study.
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic patients attending a sexual health clinic. | A cohort of 160 symptomatic people attending a sexual health clinic in the UK will be recruited to this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea
Investigators will determine the specificity and sensitivity of the novel molecular diagnostic in the detection of Mycoplasma and Gonorrhoea infections from clinical samples performed during testing of symptomatic participants. Results of the novel diagnostic will be compared to standard current laboratory test results and the results of quantitative PCR.
Measured: 3 years
Secondary outcomes (1)
Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections.
Investigators will determine the specificity and sensitivity of the novel molecular diagnostic in the detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections from clinical samples performed during testing of symptomatic participants. Results of the novel diagnostic will be compared to standard current laboratory test results for antibiotic resistance and and the results of sequencing Gonorrhoea and Mycoplasma bacteria for antibiotic resistance genes.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Oct 2019
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391035
- Sponsor's protocol ID
- CT 269508
- Acronym
- Guardian
- Status last verified
- Nov 2021
- First submitted
- 23 Dec 2021
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.
- ClinicalTrials.gov ID
- NCT05391035
- Acronym / sponsor ID
- Guardian / CT 269508
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- Cardiff University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary research question:
Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic?
Secondary research question:
Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?
Detailed description
This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail.
Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic.
Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques.
Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic.
Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID.
Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic.
This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients attending a sexual health clinic. | – | –A cohort of 160 symptomatic people attending a sexual health clinic in the UK will be recruited to this observational study. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Symptomatic patients attending a sexual health clinic in Cwm Taf Morgannwg health board, UK.
Key inclusion criteria (11 listed)
- Patients that are sexually active.
- Patients that are symptomatic with:
- Dysuria
- Urethral discharge
- Vaginal discharge
Key exclusion criteria (5 listed)
- Pregnancy.
- Aged under 16 years.
- Sexual assault case.
- Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
- Patients lacking capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea
Time frame: 3 years
Investigators will determine the specificity and sensitivity of the novel molecular diagnostic in the detection of Mycoplasma and Gonorrhoea infections from clinical samples performed during testing of symptomatic participants. Results of the novel diagnostic will be compared to standard current laboratory test results and the results of quantitative PCR.
1 secondary outcome
Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No. no plan to share participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, Bacterial and Antibiotic Resistant Infection, run by Cwm Taf University Health Board (NHS) at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.