Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, randomized, double-blind, double-dummy, multicenter, multinational study to assess the efficacy and safety of orally administered tebipenem pivoxil hydrobromide (TBP-PI-HBr) compared to intravenously (IV) administered imipenem-cilastatin in patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)

This research study is testing a new antibiotic tablet called tebipenem pivoxil for people with complicated urinary tract infections (UTIs) or acute pyelonephritis (a type of kidney infection). These types of infections can be quite serious. The study wants to see if this new tablet works as well and is as safe as a standard treatment given through a drip into the vein (imipenem-cilastatin). Participants will be randomly put into one of two groups: one receiving the new tablet, and the other receiving the standard IV treatment. We'll be looking at how well the treatments clear up the infection and improve symptoms, as well as checking for any side effects. The aim is to find out if this new tablet could be a good treatment option, potentially allowing people to take medication by mouth instead of needing hospital visits for IV treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Spero Therapeutics Inc.

Enrolment target

1,454

Start

19 Feb 2024

complicated urinary tract infection (cUTI) or acute pyelonephritis (AP)

What is this study about?

Imagine you have a really stubborn or complicated urinary tract infection (UTI), or perhaps a kidney infection, which is called acute pyelonephritis. Usually, these can be quite serious and sometimes need medicine given through a drip into your arm (intravenously, or IV). This study is looking at a new antibiotic medicine that you can take by mouth, as a tablet.

The main goal of this study is to see if this new tablet, called tebipenem pivoxil, works just as well as the standard IV treatment, and if it's safe to use. Doctors and researchers want to find out if taking a tablet can clear up these tough infections, reduce your symptoms, and fight off the germs causing the problem. They'll also be keeping a close eye on any side effects that might happen.

By comparing the new tablet to the existing IV treatment, the study hopes to find a new, easier way for people to get better from these infections. If the tablet works well, it could mean fewer trips to the hospital or clinic for IV drips, making treatment more convenient for patients in the future.

Key takeaways

The study is testing a new antibiotic tablet for serious UTIs and kidney infections.
It compares the new tablet with a standard IV (drip) treatment.
The goal is to see if the tablet is safe and works as well as the IV treatment.
Participants will be closely monitored for effectiveness and side effects.
This research could lead to more convenient treatment options for these infections.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years old or older. The study is open to both men and women.

Most importantly, you must have been diagnosed with either a complicated urinary tract infection (cUTI) or an acute kidney infection (acute pyelonephritis). These are the specific types of infections the researchers are focusing on.

There will also be other specific health checks and medical requirements that the study doctors will need to review to make sure this is the right study for you and that you can safely take part. These might include checking other health conditions you have, or other medicines you are taking, to ensure they don't interfere with the study treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a complicated urinary tract infection (cUTI) or an acute kidney infection (acute pyelonephritis)?
Are you able to attend regular clinic visits for check-ups and tests?
Are you comfortable with the possibility of receiving either a new tablet or a standard IV treatment, or a dummy version of one of them?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group would receive the new antibiotic tablet (tebipenem pivoxil), and the other group would receive the standard antibiotic given by IV (imipenem-cilastatin). All participants will also receive a 'dummy' treatment (a placebo) that looks like the other treatment, so that neither you nor your doctors know which active treatment you are getting. This helps make sure the results are fair.

Throughout the study, you'll have several visits to the clinic for check-ups, blood tests, urine tests, and to monitor your symptoms and any side effects. This will happen at specific times: during treatment, shortly after treatment finishes (End of Treatment or EOT), a bit later to see how you're doing (Test of Cure or TOC), and then a final follow-up visit (Late Follow-up or LFU).

The total duration of your participation in the study, from starting the treatment until your final check-up, will be determined by the study plan, but it generally involves a treatment period followed by several weeks of follow-up visits to ensure the infection is gone and you are well.

Potential risks and benefits

Taking part in this study might offer a potential benefit by providing you with a carefully monitored treatment for your complicated UTI or kidney infection, possibly with a new oral medication that could be more convenient. However, like all medications, both the new tablet and the standard IV treatment can have side effects, which the study team will monitor closely. There's also a chance the treatment you receive might not work as well for you as expected. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Latvia
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Unverified
Poland
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Unverified
Estonia
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Unverified
Greece
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Unverified
Slovakia
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Unverified
Bulgaria
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Unverified
Romania
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Unverified
Hungary
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Unverified
Croatia

Common questions

What is a 'complicated' urinary tract infection?

A complicated UTI is usually an infection that is harder to treat or occurs in someone with other health problems or a difference in their urinary system, making the infection more serious.

What is acute pyelonephritis?

Acute pyelonephritis is a severe infection of the kidneys, often caused by bacteria spreading from a bladder infection, which can cause fever, back pain, and other serious symptoms.

Why is it 'double-blind, double-dummy'?

This means that neither you nor your study doctors will know whether you are receiving the new tablet or the standard IV treatment. You will receive a tablet and an IV, but one of them will be a dummy (placebo). This helps ensure the study results are fair and unbiased.

Will I have to stay in hospital?

The study design aims to test a new tablet, which could potentially reduce the need for IV treatments often given in hospital. Your study doctor will discuss whether your specific condition might require any initial hospital stay or if the treatment can be managed outside of a hospital setting.

What happens if the treatment doesn’t work or I get worse?

Your safety is the priority. The study team will closely monitor your condition. If your infection doesn't improve or gets worse, or if you experience significant side effects, the study doctors will take appropriate steps, which may include stopping the study treatment and providing alternative care.