The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections. (Guardian)

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?

Study Overview

• Status: Recruiting
• Conditions: Sexually Transmitted Diseases, Bacterial; Antibiotic Resistant Infection

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Lucy Jones; Phone Number: 01443443421; Email: Lucy.Jones14@wales.nhs.uk

Study Locations

• United Kingdom
  • Pontypridd, United Kingdom, CF37 1LB
    • Recruiting
    • Lucy Jones
    • Contact: Lucy Jones; Phone Number: 01443443421; Email: Lucy.Jones14@wales.nhs.uk
  • Rhondda Cynon Taf
    • Llantrisant, Rhondda Cynon Taf, United Kingdom, CF82 7XR
      • Recruiting
      • Cwm Taf Morgannwg University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients attending a sexual health clinic in Cwm Taf Morgannwg health board, UK.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)
• Collaborators: Cardiff University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (ACTUAL): May 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Infections; Communicable Diseases; Gonorrhea; Sexually Transmitted Diseases; Sexually Transmitted Diseases, Bacterial
• Other Study ID Numbers: CT 269508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No