The study is looking for US-based participants who match the following criteria:
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.
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:
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:
Read the How to Join the UTI Study section above before clicking the button below.
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.
See the detailed information provided above.
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.
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.
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.
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.
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.
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.
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.
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.
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.
You will be in the study for about 28 days.
You will visit the study site 4 times for tests and health checks with the study doctor. These visits will occur as follows:
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.
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.
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.
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.
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.
Yes, the study has already begun and is currently accepting new participants who are interested in joining.
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.