Join A Clinical Trial For A New Investigational UTI Antibiotic
For Females Aged 12 Years Or Older Who Experience UTI
Who Can Join The Study?
The study is looking for US-based participants who match the following criteria:
- Female participants aged 12 years or older, who:
- Are not pregnant;
- Have no known anatomical abnormalities within the urinary tract; and
- Have experienced signs and symptoms of a urinary tract infection in the last 96 hours
Those who experience recurrent or chronic urinary tract infection with episodic symptoms (with symptom-free days between UTI episodes) and who are not currently experiencing symptoms may still be eligible for the study during a future episode of UTI symptoms. Additional information can be found below.
All volunteers will be screened for eligibility before entering the study. To find out whether you qualify, and how to join the study, read more below.
How To Join The UTI Study
To find out whether you qualify for the study, there are a few steps to follow. Before visiting the main study website, be sure to read these as there are specific instructions for recurrent and chronic UTI sufferers:
- Read the information above and below about study eligibility, the study itself and our FAQs
- Visit the Find a Research Center page
- Use the site finder map to locate a study site near you
- Click on the selected site to expand the information box
- Note the address and contact information of the site you have selected
If you are currently experiencing UTI symptoms, or have in the last 96 hours:
- Reach out to the clinical research study site directly using the phone number provided (as per the How to Join the UTI Study section above).
- Let the site staff know you are experiencing UTI symptoms and would like to participate in the UTI EAGLE Study
If you are not currently experiencing UTI symptoms:
You may still be able to participate in the study, but will need to wait until you experience symptoms again.
Here is what you should do to be ready:
- Reach out to the site directly using the phone number or email address provided
- Let the site staff know you experience recurrent UTI and would like instructions on how to participate in the UTI EAGLE Study the next time you have UTI symptoms
- Follow up with the study site you have chosen when you next experience UTI symptoms
Read the How to Join the UTI Study section above before clicking the button below.
Learn More About The Study
The potential new UTI antibiotic being studied is called gepotidacin. The study will assess the safety of this new investigational medicine, and how it compares to current UTI treatment.
In order to do this, gepotidacin will be compared to nitrofurantoin, an antibiotic that is commonly used to treat UTI.
Gepotidacin has been studied in people in other clinical trials, but is currently not approved by the United States Food and Drug Administration (FDA) for use in people with bladder infections. It is therefore considered experimental. Nitrofurantoin is approved by the FDA for the treatment of UTI.
Each study participant will be placed at random into a study treatment group to receive either gepotidacin or nitrofurantoin. Neither the participant nor the doctor will know which treatment is provided. This is to make sure the results of each group being studied are handled in the same way.
The healthcare company GlaxoSmithKline (also called “GSK”) is sponsoring this study, which is one of two similar studies referred to as the EAGLE Studies. GSK discovers and makes vaccines, medicines, and other health products. They pay the study doctor and study research sites to run this study.
Frequently Asked Questions
How do I join the study?
See the detailed information provided above.
If I’m interested in the study but not located in the US, can I still participate?
You can find more information about other study research sites here and here.
What happens if I contact the study research site and they tell me that I am not eligible to join the study?
There is a chance that you may not be eligible for the study due to your medical history or a pre-existing condition. In this case, the study doctor or nurse will let you know the reason and advise you on alternative treatment options for your UTI.
If I’m not experiencing symptoms right now, can I still join the study?
Female volunteers who experience recurrent or chronic UTI where symptoms occur as distinct episodes and are not continuous may be eligible to join the study. Enrolment into the study is only possible when signs and symptoms of a urinary tract infection have occurred in the last 96 hours. If you are not currently experiencing symptoms but anticipate future episodes of UTI, it is important to locate and contact a study research center for more information on what to do when you next experience symptoms. This way you will be prepared to be screened for the study as soon as you have symptoms, and can receive treatment as quickly as possible.
What treatment will I receive during the study?
You will be placed at random into a treatment group to receive either the study medicine (gepotidacin) or a current medicine (nitrofurantoin) used to treat UTIs. Both of these medicines are antibiotics. You and the doctors will not know which group you are in. This is to make sure the results of each group being studied are handled in the same way.
Will I be able to find out which medicine I took?
Only in case of a medical emergency, you, the study staff, and your healthcare provider will be told what study treatment you received during the study. At the end of the study, all the research sites will be provided with a summary of the study results and access to treatment information about all of their participants. Participants can request details on the treatment they received once the study results are available.
How are the treatment groups assigned?
A computer is used to assign study participants into study treatment groups by chance. This is called randomization. You will have a 1 in 2 (50%) chance of being placed in either treatment group (gepotidacin or nitrofurantoin). You and the study doctor will not know which group you are in. This is to make sure the results of each group being studied are handled in the same way.
How will I take the study medicine?
You will take the study medicine 2 times a day by mouth with water and with food for 5 days. You will be given a dosing card to write down the date and time when you take each dose of study medicine.
Has the new investigational medicine already been studied in people?
Gepotidacin has been studied in people in other clinical trials, but is currently not approved by the United States Food and Drug Administration (FDA) for use in people with bladder infections and is therefore considered experimental. Nitrofurantoin is approved by the FDA for the treatment of UTI.
Are there any side effects from the study medicine?
Like with all medicines, there is a chance for side effects. It is very important to tell the study team about any changes in your health or if you are not feeling well. If you are interested in joining the study, the study doctor will explain more about any potential side effects.
What happens if the study medicine does not clear my bladder infection?
You will be assessed at the Test of Cure (TOC) Visit 10-13 days after starting study treatment and again at the Follow-up Visit 25-31 days after starting study treatment. If your symptoms become troublesome at any other time before or between visits, please speak to your study doctor, who will advise you on treatment options.
How long will I be in the study?
You will be in the study for about 28 days.
How many times will I have to go to the study research site?
You will visit the study site 4 times for tests and health checks with the study doctor. These visits will occur as follows:
How long will I need to be at the study research site for each visit?
Most visits will take about 2 to 4 hours. If you choose, you may be able to answer some questions over the phone or video call to lessen the amount of time you are at the study site. However, you will still be required to come to the study site a total of 4 times for tests.
What kind of tests will I have at study site visits?
At study visits, you will have a checkup, and the study doctor will measure your height, weight, blood pressure, body temperature, and pulse. You will also have blood tests and urine tests. You may have a non-invasive, painless test called an electrocardiogram (ECG), which measures your heart’s electrical activity.
What are the benefits of being in the study?
Antimicrobial resistance is a growing concern, so research into new antibiotics is an important step in being able to provide additional treatment options to patients with recurrent or chronic UTI. You may or may not directly benefit from being in the clinical study. However, the information collected may help doctors learn more about bladder infections and find new medicines to help treat them.
Do I have to pay anything to be in the study?
Taking part in this study will not cost you anything. You will receive the study medicine, the study visits and all the study tests at no cost to you. You may be able to get reimbursed for your travel expenses to and from the study research site.
Do I have to stay in the study if I decide to join?
No, being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.
Has the study already begun?
Yes, the study has already begun and is currently accepting new participants who are interested in joining.
Do I need health insurance or a doctor referral to participate?
Health insurance and doctor referrals are not required in order to participate. Potential participants can learn how to join the study by clicking the button below. If you have already reviewed the instructions above on how to join the study, click the button below to go directly to finding a study site.