AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

E. coli Urinary Tract Infection Study

Are you interested in helping to develop new medicines? This study is looking into a new treatment for urinary tract infections (UTIs) caused by E. coli bacteria. These infections are very common and can be uncomfortable. This is the very first time this new medicine will be given to people. Researchers want to understand how it behaves in the human body, such as how it's absorbed, distributed, and cleared. Your participation is vital as it helps scientists gather important information about its safety and effects. This early research is an important step towards potentially offering better treatment options for UTIs in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Phagenix

Enrolment target

Start

06 May 2024

Bacterial urinary infection

What is this study about?

You might have heard of urinary tract infections, often called UTIs. They're a common type of infection that can affect your bladder or kidneys, making you feel uncomfortable with symptoms like needing to pee often, a burning feeling when you pee, or tummy pain. Many UTIs are caused by a type of bacteria called E. coli.

Doctors and scientists are always looking for better ways to treat these infections. This study is testing a brand-new medicine designed to fight E. coli UTIs. It's the very first time this medicine will be given to people, so the main goal is to see how it works and if it's safe.

By taking part, you'd be helping scientists learn crucial information about this new medicine. This early research is a vital step in developing new treatments that could one day help many people who suffer from UTIs. It's about figuring out how the medicine moves through your body and what effects it might have, paving the way for future studies.

Key takeaways

This study is testing a brand-new medicine for E. coli urinary infections for the first time in people.
It helps scientists understand how the medicine works in the human body and if it's safe.
You must be 18 or older to potentially take part, and both men and women are welcome.
Participation involves medical checks and closely observing how your body reacts to the new medicine.
Your involvement could help develop better treatments for UTIs in the future.

Who may be eligible?

This study is looking for adults who are 18 years old or older. Both men and women are welcome to take part.

Because this is the very first time this medicine is being tested in humans, the study will likely be looking for people who are generally healthy. They will want to make sure any effects seen are related to the new medicine and not other health conditions.

There will be other specific health checks to make sure the study is safe for you. These will be discussed in detail by the study team, but generally, if you have certain ongoing health problems or take particular medications, you might not be able to join.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Are you able to commit to several study visits, possibly including a short clinic stay?
Do you understand that this is a new medicine being tested for the first time in people?
Are you happy to undergo medical tests like blood and urine samples?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would first have a screening visit to check your health and make sure you're suitable for the study. If you qualify, you'd be given the new study medicine. This is usually given in a special research ward or clinic where you might stay for a short period of time, perhaps a few days, so doctors can carefully monitor you.

During your time in the study, you would have regular checks, which might include blood tests, urine tests, and having your blood pressure and heart rate monitored. This helps doctors see how the medicine is working in your body and if you have any side effects. You might also have follow-up visits after you leave the clinic to make sure you're continuing to do well. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit is contributing to medical science, which could lead to better treatments for UTIs in the future. You will also receive careful medical monitoring by a specialist team. However, as this is a new medicine, there's always a risk of unexpected side effects, some of which could be mild, like a headache, while others could be more serious. All known risks will be fully explained before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is an E. coli urinary tract infection?

It's a common infection in your bladder or kidneys, usually caused by a type of bacteria called E. coli, leading to symptoms like needing to pee often or pain when you go.

Why is this study giving the medicine to healthy people first?

Because it's the first time this medicine is being given to humans, doctors want to see how it works and if it's safe in people without other health issues, to get a clear picture of its effects.

Will I get paid to take part?

Payment for participation to cover your time and inconvenience is common in early-stage studies. This will be fully discussed with you if you are considered for the study.

How long will I need to be in the study?

The exact length of the study will vary, but it will involve an initial screening, potentially a short stay in a clinic, and then follow-up appointments. The full timeline will be explained before you decide to join.

Can I leave the study once I've joined?

Yes, you are free to withdraw from the study at any time, for any reason, without having to explain why, and it won't affect your regular medical care.