Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000420549
Ethics application status
Approved
Date submitted
12/02/2024
Date registered
5/04/2024
Date last updated
5/04/2024
Date data sharing statement initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
CARGo: Investigating the Efficacy of Carbamazepine for the treatment of gonorrhoea in women
Scientific title
CARGo: Investigating the Efficacy of Carbamazepine for the treatment of gonorrhoea in women
Secondary ID [1] 311521 0
None
Universal Trial Number (UTN)
Trial acronym
CARGo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gonorrhoea 332870 0
Condition category
Condition code
Infection 329589 329589 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Carbamazepine 100mg tablets administered orally once 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.
Intervention code [1] 327975 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337368 0
To determine the efficacy of oral carbamazepine as a treatment for uncomplicated Neisseria gonorrhoeae (N.gonorrhoeae) cervical infections in women
Assessment method [1] 337368 0
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
Timepoint [1] 337368 0
Baseline and at Visit 2 (day 3-7 days post commencing intervention)
Primary outcome [2] 337369 0
To determine that carbamazepine disrupts the interaction between N.gonorrheoae and cervical epithelial cells
Assessment method [2] 337369 0
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
Timepoint [2] 337369 0
Baseline and at visit 2 ( Day 3-7 post commencing intervention)
Secondary outcome [1] 431593 0
To determine the efficacy of oral carbamazepine as a treatment for uncomplicated N.gonorrhoeae pharyngeal infections in women
Assessment method [1] 431593 0
Pharyngeal N.gonorrhoeae identified by NAAT following carbamazepine treatment
Timepoint [1] 431593 0
Baseline and at visit 2 ( Day 3-7 post commencing intervention)
Secondary outcome [2] 431594 0
To determine the safety, tolerability and acceptability of oral carbamazepine as a therapeutic option for women with N.gonorrheoae infection (assessed as composite outcome in view of existing safety profile)
Assessment method [2] 431594 0
Adverse event assessment and reporting following carbamazepine dosing including serious adverse events, serious unexpected adverse reactions and adverse events of special interest. Relatedness will be assessed against reported adverse events in the full product information for carbamazepine. Examples of common known adverse events for carbamazepine include: headache, increases in seizure frequency in patients with atypical absences, accommodation disorders (e.g. blurred vision), urticaria which may be severe, allergic dermatitis, fatigue, increased gamma-glutamyltransferase (due to hepatic enzyme induction), and increased blood alkaline phosphatase
Timepoint [2] 431594 0
Visit 2 (3-7 days post commencing intervention) and Visit 3 (7-18 days post commencing intervention)
Secondary outcome [3] 431595 0
To describe local and systemic immunological responses to uncomplicated N.gonorrhoeae infections in women (composite outcome)
Assessment method [3] 431595 0
Antibody responses measured by Neisseria Heparin Binding Assay (NHBA) and serum bactericidal assay (SBA) titres in serum and cervical (+/- pharyngeal and rectal if consented) samples
Timepoint [3] 431595 0
Visit 2 (3-7 days post commencing intervention) and Visit 3 (7-18 days post commencing intervention)
Secondary outcome [4] 432205 0
To determine the efficacy of oral carbamazepine as a treatment for uncomplicated N.gonorrhoeae rectal infections in women
Assessment method [4] 432205 0
Rectal N.gonorrhoeae identified by NAAT following carbamazepine treatment
Timepoint [4] 432205 0
Baseline and at visit 2 ( Day 3-7 post commencing intervention)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315812 0
Hospital
Name [1] 315812 0
Gold Coast Hospital and Health Service
Country [1] 315812 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Country
Australia
Secondary sponsor category [1] 317941 0
None
Name [1] 317941 0
Country [1] 317941 0
Other collaborator category [1] 282953 0
University
Name [1] 282953 0
Griffith University
Country [1] 282953 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314670 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314670 0
Ethics committee country [1] 314670 0
Australia
Date submitted for ethics approval [1] 314670 0
25/08/2023
Approval date [1] 314670 0
21/09/2023
Ethics approval number [1] 314670 0
HREC/2023/QGC/99859

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 132350 0
Dr Caroline Thng
Address 132350 0
Gold Coast Sexual Health Service, Level 4, 16-30 High Street, Southport, 4215 Queensland
Country 132350 0
Australia
Phone 132350 0
+61 426991037
Email 132350 0
caroline.thng@health.qld.gov.au
Contact person for public queries
Name 132351 0
Caroline Thng
Address 132351 0
Gold Coast Sexual Health Service, Level 4, 16-30 High Street, Southport, 4215 Queensland
Country 132351 0
Australia
Phone 132351 0
+61 426991037
Email 132351 0
caroline.thng@health.qld.gov.au
Contact person for scientific queries
Name 132352 0
Caroline Thng
Address 132352 0
Gold Coast Sexual Health Service, Level 4, 16-30 High Street, Southport, 4215 Queensland
Country 132352 0
Australia
Phone 132352 0
+61 426991037
Email 132352 0
caroline.thng@health.qld.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data Privacy



What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.