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

NCT05391035 | Completed

• 1 other identifier: CT 269508
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

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?

Conditions

Sexually Transmitted Diseases, Bacterial; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections.

  3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• Cardiff University: collaborator

Study Sites (2)

Cwm Taf Morgannwg University Health board

Llantrisant, Rhondda Cynon Taf, CF82 7XR, United Kingdom

Location

Lucy Jones

Pontypridd, CF37 1LB, United Kingdom

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: May 25, 2022
• Study Start: October 1, 2019
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 20, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)