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Comparing the effectiveness of 7 days versus 14 days of ciprofloxacin or ceftriaxone for treating kidney infection in kidney transplant recipients

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What is this study about?

This study focuses on Graft Pyelonephritis, which is a type of infection in the kidney that has been transplanted into a patient. The purpose of the study is to determine if a shorter course of antibiotic treatment lasting 7 days is as effective and safe as the standard 14-day treatment course.

Participants in the study will receive different types of antibiotics. Some may receive Ceftriaxone, which is administered through an Intravenous line, meaning the medicine is delivered directly into a vein. Others may receive Ciprofloxacin. The study compares these medications when given for a shorter period versus the usual longer period to see if the shorter duration provides the same level of healing and safety.

Who Can Join the Study?

  • You must be an adult, meaning you are 18 years of age or older.
  • You must have received a kidney transplant, which is a surgery where a healthy kidney from a donor is placed into your body to replace a non-working kidney.
  • You must be experiencing acute graft pyelonephritis, which is a sudden infection in the transplanted kidney.
  • The infection must be identified at any time between your transplant surgery and 48 hours after you have started taking antibiotics (medicine used to kill bacteria).
  • You must be able to provide written informed consent, which means you agree to participate in the study after being given all the necessary information.
  • If you are unable to sign the consent form yourself, a legal representative (someone legally authorized to make decisions for you) can sign it instead.

Who Cannot Join the Study?

  • You are experiencing clinical instability, which means your body is not maintaining steady, healthy functions, specifically within 48 hours of starting antibiotics. This includes having hypotension (dangerously low blood pressure), anuria (the inability of the kidneys to produce urine), a fever of 38ºC or higher, the need for vasopressors (strong medications used to raise blood pressure), or the need to stay in the intensive care unit (a special hospital area for patients needing constant, close monitoring).
  • You are currently pregnant or breastfeeding.
  • You have known physical changes in your body that make you more likely to get urinary tract infections, such as vesicoureteral reflux (a condition where urine flows backward from the bladder into the tubes that connect to the kidneys) or obstructive prostatic hypertrophy (an enlarged prostate gland that blocks the flow of urine).
  • You have a urinary catheter, which is a flexible tube inserted into the body to help drain urine from the bladder or kidneys.
  • You have complications like a urinary obstruction (a blockage that stops urine from flowing) or a kidney abscess (a painful collection of pus inside the kidney).
  • You have received a kidney transplant and were admitted to the hospital for graft pyelonephritis (an infection in the transplanted kidney) within the last 30 days.
  • You are already participating in a different medical study that involves using antibiotics to treat a kidney infection.
  • You have already been a participant in this specific study before.
  • You or your legal representative are unable or unwilling to provide informed consent, which is the formal written agreement to take part in a study after understanding all the details.
  • You have any medical, mental health, or family situation that the doctor believes might make it unsafe or difficult for you to take part in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fundacio Puigvert Barcelona Spain
Hospital Clinic De Barcelona Barcelona Spain
Hfwgtlvc Veyv dsnvzuha Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
02.01.2026

Trial locations

Investigated drugs:

Ciprofloxacin is an antibiotic used to treat bacterial infections. In this study, it is being tested as an intravenous treatment and also used as an oral medication for comparison.

Ceftriaxone is an antibiotic used to treat various bacterial infections. In this study, it is being used as an intravenous treatment for comparison.

Investigated diseases:

Graft pyelonephritis – This is a type of bacterial infection that affects the kidney transplant in a person who has received a donor organ. The infection occurs when bacteria enter the urinary tract and spread to the transplanted kidney. It causes inflammation within the kidney tissue and the renal pelvis. As the condition progresses, the bacteria can multiply within the organ, potentially leading to further complications in the transplant. The infection typically manifests as an inflammatory response specifically located in the transplanted tissue.

Trial ID:
2025-523120-53-00
Protocol code:
KTI2023
Trial Phase:
Human Pharmacology (Phase I) – Other

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