Clinical trial NCT05391035: The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.
Official title: The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases, Bacterial
Antibiotic Resistant Infection
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
First posted: 2022-05-25
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients attending a sexual health clinic in Cwm Taf Morgannwg health board, UK.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Patients that are sexually active.
* Patients that are symptomatic with:
* Dysuria
* Urethral discharge
* Vaginal discharge
* Rectal discharge
* Dysparenia (pain during sex)
* Pelvic pain
* Testicular pain
* Post-coital bleeding (bleeding after sex)
* Vulval/Glans/Perianal pain.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea
timeFrame: 3 years
Secondary outcomes:
measure: Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections.
timeFrame: 3 years
Other outcomes:
Locations:
city: Llantrisant
country: United Kingdom
facility: Cwm Taf Morgannwg University Health board
state: Rhondda Cynon Taf
city: Pontypridd
country: United Kingdom
facility: Lucy Jones
Study officials:
References: