OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

University of Oxford

Status: Completed

Conditions: Gonorrhea

Treatments: Other: Blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT05613725

OptiGon

Details and patient eligibility

About

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.

Full description

On the day the patient attends the Sexual Health Clinic, they will be given the PIS to consider participation to the study following a confirmed positive result for N. gonorrhoea infection. Following written informed consent, a venous blood sample will be collected (up to 26 ml) on the same day. This will conclude that participant's involvement to the study.

The blood sample will be transported to the laboratory at the Jenner Institute, University of Oxford for further analysis.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.