CARGo: Investigating the Efficacy of Carbamazepine for the treatment of gonorrhoea in wome

Phase 2

Conditions: gonorrhoea
Infection - Sexually transmitted infections

Registration Number: ACTRN12624000420549

Lead Sponsor: Gold Coast University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 75

Inclusion Criteria

Cis-gender women
Aged greater than or equal to 18 years old
Self-reported or confirmed sexual contact of Neisseria gonorrhoea (NG) infection
Willing to test and wait” for NG (ie. Not take any antibiotics which may treat NG) until results available
Willing to abstain from sex until completion of all study visits

Exclusion Criteria

Any history of seizures

Symptoms suggesting NG infection (eg. Change in vaginal discharge, intermenstrual bleeding)

Symptoms suggesting complicated NG infection (eg. Pelvic inflammatory disease)

Test results suggesting NG infection (microscopy with Gram negative intracellular diplococci, positive N. gonorrhoea NAAT or NAAT) within the last 14 days

Have had unprotected sex with the index case of gonorrhoea within the last 7 days (window period for gonorrhoea test and potential false negative test)

Has received any antibiotics for the treatment of NG within the last 14 days

Any contraindication to receiving carbamazepine

Already taking carbamazepine or oxcarbazepine for existing health conditions

Taking concomitant medication which may be contraindicated or have significant interactions with carbamazepine

Currently or intending to become pregnant within the study period

Breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of oral carbamazepine as a treatment for uncomplicated Neisseria gonorrhoeae (N.gonorrhoeae) cervical infections in women [Cervical N.gonorrhoeae identified by nucleic acid amplification test (NAAT) following carbamazepine treatment in women who have been identified to have cervical N.gonorrhoeae infections Baseline and at Visit 2 (day 3-7 days post commencing intervention)];To determine that carbamazepine disrupts the interaction between N.gonorrheoae and cervical epithelial cells [Laboratory functional assays (including adherence assays and gonococcal survival assays) to determine the inhibition of gonococcal adherence to cervical cells in patients with therapeutic carbamazepine levels Baseline and at visit 2 ( Day 3-7 post commencing intervention)]

Secondary Outcome Measures