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NCT05613725 Clinical Trial

OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Gonorrhea Clinical Trial

Official title:
Optimising Laboratory Assays for Immune Responses to Gonococcus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05613725
Other study ID # OptiGon
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2, 2022
Est. completion date April 30, 2024

Study information
Verified date November 2022
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample collection
Blood sample collection

Locations
Country Name City State
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford

Sponsors (1)
Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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