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STUDY TO FIND OUT WHETHER A SHORTER ANTIBIOTIC TREATMENT (7 DAYS) IS AS EFFECTIVE AND SAFE AS THE USUAL ONE (14 DAYS) IN PATIENTS WITH AN INFECTION IN THEIR TRANSPLANTED KIDNEY (KTI)
EU CTIS ID: 2025-523120-53-00
What this study is testing
The primary objective of the study is to demonstrate the non-inferiority of a 7-day treatment regimen compared to 14 days of antibiotic treatments used in usual clinical practice in patients with graft pyelonephritis.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult kidney transplant recipients ≥ 18 years of age, of both sexes, who experience an episode of acute graft pyelonephritis at any time from the transplant to 48 hours after the start of antibiotic treatment.
- Patients must be willing and able to provide written informed consent for the trial. If a subject is unable to provide written informed consent independently, a legal representative may do so in their place.
You likely can't join if
- Clinical instability 48 hours after the start of antibiotic treatment due to an episode of acute graft pyelonephritis defined as: hypotension, anuria, fever equal to or greater than 38ºC, need for vasopressor drugs or admission to the intensive care unit.
- Pregnant or breastfeeding patients.
- Patients with known anatomical alterations that predispose to urinary tract infections (such as vesicoureteral reflux or obstructive prostatic hypertrophy).
- Presence of urinary catheters such as bladder catheters or ureteral catheters.
- Presence of complications such as urinary obstruction or kidney abscess.
- Kidney transplant recipients admitted for an episode of graft pyelonephritis in the previous 30 days.
See the full eligibility criteria
- Adult kidney transplant recipients ≥ 18 years of age, of both sexes, who experience an episode of acute graft pyelonephritis at any time from the transplant to 48 hours after the start of antibiotic treatment.
- Patients must be willing and able to provide written informed consent for the trial. If a subject is unable to provide written informed consent independently, a legal representative may do so in their place.
- Clinical instability 48 hours after the start of antibiotic treatment due to an episode of acute graft pyelonephritis defined as: hypotension, anuria, fever equal to or greater than 38ºC, need for vasopressor drugs or admission to the intensive care unit.
- Pregnant or breastfeeding patients.
- Patients with known anatomical alterations that predispose to urinary tract infections (such as vesicoureteral reflux or obstructive prostatic hypertrophy).
- Presence of urinary catheters such as bladder catheters or ureteral catheters.
- Presence of complications such as urinary obstruction or kidney abscess.
- Kidney transplant recipients admitted for an episode of graft pyelonephritis in the previous 30 days.
- Participation in another clinical trial in which the protocol establishes antibiotic treatment for pyelonephritis.
- Previous inclusion in the present study.
- No authorization from the patient or their legal representative to sign the informed consent.
- Any medical, psychiatric, or family condition that, in the investigator's judgment, could jeopardize or compromise the patient's ability to participate in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.