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

Antibiotic Resistant Infection Clinical Trial

— Guardian  

Official title:

The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391035
• Other study ID #: CT 269508
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Cwm Taf University Health Board (NHS)
• Contact: Lucy Jones
• Phone: 01443443421
• Email: Lucy.Jones14[@]wales.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Gonorrhea
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial

Locations

Country	Name	City	State
United Kingdom	Cwm Taf Morgannwg University Health board	Llantrisant	Rhondda Cynon Taf
United Kingdom	Lucy Jones	Pontypridd

Sponsors (2)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)	Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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