AuthorisedPhase III and phase IV (Integrated)Interventional

Prospective Multicenter Randomized Non-Inferiority Study Comparing 7 Days Versus 14 Days of Antibiotic Treatment for Graft Pyelonephritis in Kidney Transplant Recipients (KTI)

This research study is looking at the best way to treat a certain type of kidney infection called 'graft pyelonephritis' in people who have had a kidney transplant. Doctors usually treat these infections with antibiotics. This study aims to find out if treating with antibiotics for 7 days is as good as treating for 14 days. The main goal is to see if a shorter course of antibiotics can still prevent serious issues like needing to go back to the hospital, the infection coming back, or other health problems within 90 days. The study will also look at side effects and how patients recover.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

360

Start

02 Mar 2026

Graft pyelonephritis in kidney transplant recipients

What is this study about?

This study is focused on people who have received a kidney transplant and then develop a kidney infection in their new kidney, which doctors call 'graft pyelonephritis.' This is a serious infection, and antibiotics are used to treat it.

Currently, doctors might treat this type of infection with antibiotics for different lengths of time, often around 7 or 14 days. This study wants to find out if giving antibiotics for 7 days is just as effective as giving them for 14 days. If a shorter course of treatment works well, it could mean fewer side effects from antibiotics and potentially less time spent in the hospital for patients.

The researchers will compare two groups of patients. One group will receive antibiotics for 7 days, and the other will receive them for 14 days. They will then carefully watch both groups for 90 days after their treatment. They will be checking for things like whether the infection comes back, if a patient needs to be readmitted to the hospital, or if there are any other serious health issues.

Key takeaways

This study is for kidney transplant recipients with a kidney infection.
It compares 7 days versus 14 days of antibiotic treatment.
The main aim is to see if shorter treatment is equally effective and safe.
Participants will be followed for 90 days.
The study uses common antibiotics like Ciprofloxacin or Ceftriaxone.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. This study is open to both men and women.

More specific details about your health and medical history, particularly related to your kidney transplant and the current infection, would be assessed by the study doctors to determine if the study is right for you. They will need to make sure your situation fits the study's specific requirements to ensure your safety and the accuracy of the research.

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 received a kidney transplant?
Do you currently have a kidney infection in your transplanted kidney?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would first receive treatment for your kidney infection, either 7 days or 14 days of antibiotics (Ciprofloxacin or Ceftriaxone) as decided by the study. During your hospital stay, doctors would monitor you closely.

After you leave the hospital, the study team would follow up with you for 90 days. This follow-up would involve checking your health, possibly through appointments or phone calls, to see how you are recovering, if the infection returns, or if you have any side effects. You might also have blood tests or urine tests, for example, to check your kidney function and look for any remaining infection.

Potential risks and benefits

Taking part in this study might mean you receive a shorter course of antibiotics, which could potentially reduce antibiotic side effects. However, there's also a chance that a shorter course might not fully clear the infection, requiring further treatment. A longer course of antibiotics carries a higher risk of antibiotic-related side effects. As with any medical study, there's always a possibility of unforeseen risks. You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

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

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Unverified
Spain

Common questions

What is 'graft pyelonephritis'?

It's a kidney infection that happens in a transplanted kidney.

What are antibiotics?

Antibiotics are medicines used to treat infections caused by bacteria.

Why is the study comparing 7 vs. 14 days?

The study wants to see if a shorter treatment (7 days) is just as effective as a longer one (14 days) to treat the infection.

How long will I be followed in the study?

You would be followed for 90 days after you join the study.

Can I choose which treatment length I get?

No, the treatment length (7 or 14 days) would be decided by chance, like flipping a coin, to ensure a fair comparison.