OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

NCT05613725 | Completed

• 1 other identifier: OptiGon
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study. Blood from otherwise healthy patients presenting with confirmed N.gonorrhoea infection, prior to treatment, will be collected to (i) allow the optimisation of assays assessing the immune response to gonococcus and (ii) assess whether N. gonorrhea specific responses can be detected on ELIspot +/- flow cytometry. The investigators plan to recruit up to 30 adults (men and women, aged 18-50 years) who have been diagnosed with confirmed N.gonorrhoea infection at the Sexual Health Clinic at the Oxford University Hospitals NHS Foundation Trust. The investigators will collect blood samples from consenting participants prior to them receiving curative antibiotic treatment.

Conditions

Gonorrhea

Outcome Measures

Primary Outcomes (1)

• Cellular immune response

  Cellular immune response detected by ELISpot +/- Flow cytometry from PBMCs collected from the blood of patients presenting with confirmed N.gonorrhoea infection.

  Blood sampling at enrolment

Interventions

Blood sample collection OTHER

Blood sample collection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18-50 years) attending Oxford University Hospitals NHS Foundation Trust with confirmed untreated N. gonorrhoea infection

You may qualify if:

• Adults (18-50 years) attending Oxford University Hospitals NHS Foundation Trust with untreated confirmed N. gonorrhoea infection confirmed by either:
• Nucleic acid test
• Microscopy of urethral discharge

You may not qualify if:

• Have already received antimicrobial therapy to treat the N. gonorrhoea infection
• Have not provided written, informed consent.
• Presence of any known medical condition which, in the opinion of the local investigator, makes the donation of 26 mls of blood unsafe.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human blood samples

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Calman MacLennan

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: December 2, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 21, 2024

Record last verified: 2022-11

Locations

GB (1)