OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Sponsor

University of Oxford (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05613725

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational study. Blood collected from otherwise healthy patients presenting with urogenital 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 urogenital 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.

Condition or Disease	Intervention/Treatment	Phase
Gonorrhea	Other: Blood sample collection

Detailed 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 urogenital N. gonorrhoea infection. Following written informed consent, a venous blood sample will be collected (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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Optimising Laboratory Assays for Immune Responses to Gonococcus

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Outcome Measures

Primary Outcome Measures

Cellular immune response [Blood sampling at enrolment]
Cellular immune response detected by ELISpot +/- Flow cytometry from PBMCs collected from the blood of patients presenting with urogenital N.gonorrhoea infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Have ave already received antimicrobial therapy to treat the urogenital N. gonorrhoea infection
Have not provided written, informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom

Sponsors and Collaborators

University of Oxford

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oxford

ClinicalTrials.gov Identifier:

NCT05613725

Other Study ID Numbers:

OptiGon

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 18, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gonorrhea

Study Results

No Results Posted as of Nov 18, 2022