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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Assignment to a treatment group
After joining the study, an assignment is made to one of two treatment groups to manage graft pyelonephritis, which is an infection in the transplanted kidney.
Step 2
Administration of antibiotics
The treatment involves receiving antibiotics, which are medicines used to fight infections, through an intravenous method, meaning the medicine is delivered directly into a vein.
Step 3
Treatment regimens
One group receives a 7-day course of treatment, while the other group receives a 14-day course of treatment.
Step 4
Medication details
Depending on the assigned group, the medication may be ciprofloxacin, administered as 1 gram via intravenous injection, or 500 milligrams taken by mouth.
The medication may also be ceftriaxone, administered as 1 gram via intravenous injection.
Step 5
Follow-up monitoring
Monitoring of health status continues for 90 days after joining the study.
This period includes checks for kidney function, potential rejection of the transplanted kidney, and urine cultures to check for bacteria at 30 days and 90 days.

Who can join the trial?

6 criteria

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 trial?

10 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
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Fundacio Puigvert
Barcelona, Spain
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Hospital Clinic De Barcelona
Barcelona, Spain

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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.

What is already known about the treatment

Ciprofloxacin
This medication is an antibiotic taken by mouth in pill form to treat various bacterial infections. It is a well-established treatment that works by stopping bacteria from copying their DNA, which prevents them from growing and multiplying. Classified as a fluoroquinolone, it is commonly used to fight infections in the urinary tract and other body systems.
Ceftriaxone
This antibiotic is administered through an intravenous injection or infusion to treat serious bacterial infections. It belongs to a group of drugs called cephalosporins and works by preventing bacteria from building their protective cell walls, causing them to break apart. It is widely used in hospitals to treat severe infections, including those affecting the kidneys and bloodstream.

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.