The EAGLE study is a randomised, open label clinical trial. The study is testing the safety and effectiveness of a new antibiotic, Gepotidacin. The study will compare this treatment to the current, standard treatment for gonorrhoea.
Melbourne Sexual Health Centre is one of a number of international sites where the EAGLE study is taking place.
This study is funded by GlaxoSmithKline (GSK) UK and is being carried out in partnership with local sponsor, PPD Australia Pty Ltd.
This study is registered with Clinical Trials under protocol number NCT04010539.
About gonorrhoea
Gonorrhoea is one of the most common sexually transmissible infections (STIs) globally.
Gonorrhoea can cause:
- unusual vaginal, anal or penile discharge
- discomfort when urinating
- irregular vaginal bleeding
- pelvic pain, especially during vaginal sex
- redness around the opening of the penis
If not treated, gonorrhoea can:
- spread to the uterus and fallopian tubes causing pelvic inflammatory disease (PID). PID may lead to complications, including infertility.
- continue to be transmitted from one person to another
Gonorrhoea is developing resistance to the antibiotics used as treatment. This means that gonorrhoea is becoming more difficult to treat effectively.
About the study
The EAGLE study is a randomised, open label clinical trial. The study is testing the safety and effectiveness of a new antibiotic, Gepotidacin. The study will compare this treatment to the current, standard treatment for gonorrhoea.
People involved in the study will be divided into two groups.
- Gepotidacin group: this group will take gepotidacin
- Standard group: this group will take the standard treatment for gonorrhoea
The effects of the medicines, good and bad, will be compared.
What is randomised controlled research?
Randomised controlled research means that we put people into groups and give each group different treatment.
We do this so we can compare the results of the different treatments to see if one is better than the other. To try to make sure the groups are the same, each participant is put into a group by chance (random).
What's involved
All people participating in the study will be asked to complete three visits as part of the study. The visits will take place over a 21 day period.
You will be asked to:
- speak to one of our research nurses about the study
- provide informed consent to participate in the study
- answer a range of questions about symptoms, age, background, sexual history, health history and current medications
- complete a physical examination
- provide blood and urine sample
- have a urethral or vaginal swab
- have an electrocardiogram to record the electrical activity of your heart
- have a drug and alcohol test
You will not be paid for participating in this research project. You may be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research visit.
Find out more by reading our patient information sheet.
Who we want to talk to
If you are diagnosed with uncomplicated urethral gonorrhoea at Melbourne Sexual Health Centre, one of our research nurses will call you to talk about the study.
Ethics
All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the Alfred Hospital HREC.
This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies. Approval has been given by the Alfred Hospital HREC which reviews ethics applications for research carried out at the Melbourne Sexual Health Centre.