- How do I join the study?
- What treatment will I receive during the study?
- How are the treatment groups assigned?
- Will I be able to find out which medicine I took?
- How will I take the study medicine?
- Has the new medicine already been studied in people?
- Are there any side effects from the study medicine?
- What happens if the study medicine does not clear my bladder infection?
- How long will I be in the study?
- How many times will I have to go to the research center?
- How long will I be at the research center for visits?
- What kind of tests will I have at research center visits?
- What are the benefits of being in the clinical study?
- Do I have to pay anything to be in the study?
- Who is sponsoring the study?
- Do I have to stay in the study if I decide to join?
- Has the study already begun?
- What happens if I contact the research center and they tell me that I am not eligible to join the study?
How do I join the study?
Click here to find a research center near you and call the number listed for more information.
What treatment will I receive during the study?
You will be placed by chance 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.
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.
Will I be able to find out which medicine I took?
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.
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 the study medicine.
Has the new 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 you are still experiencing signs and symptoms suggestive of infection recurrence or relapse, your study doctor will advise you on treatment options at these visits. If your symptoms become troublesome any other time before follow up, please speak to your study doctor.
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 research center?
You will visit the research center 4 times for tests and health checks with the study doctor.
How long will I be at the research center for visits?
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 research center. However, you will still be required to come to the research center a total of 4 times for tests.
What kind of tests will I have at research center visits?
At research center 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 clinical study?
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 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 research center.
Who is sponsoring the study?
The healthcare company GlaxoSmithKline (also called “GSK”) is sponsoring the EAGLE Study. GSK discovers and makes vaccines, medicines, and other health products. They pay the study doctor and research center to run this study.
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 EAGLE Study has already begun and is currently accepting new participants who are interested in joining.
What happens if I contact the research center 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.