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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000420549

Acronym

CARGo

Enrollment

Registered

2024-04-05

Start date

2025-08-26

Completion date

2025-10-01

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

CARGo is a Phase IIb single arm efficacy study of oral carbamazepine in women to treat uncomplicated Neisseria gonorrhoeae (NG) infection. The study applies a window-of-opportunity design where participants will receive carbamazepine whilst awaiting the results of a standard of care NG test. Asymptomatic women who have been identified as a sexual contact of a person confirmed to have gonococcal infection will be targeted for recruitment

Interventions

Carbamazepine 100mg tablets administered orally twice a day, taken until patient attends for Visit 2 (anticipated to be 5-7 days). Adherence will be recorded by a dosing diary which will be attached/ included in the medication pack. Adherence will also be measured by serum carbamazepine levels.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results