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Study on 7-Day vs. 14-Day Antibiotic Treatment for Kidney Infection in Transplant Patients Using Bromhexine Hydrochloride, Trimethoprim, and Fluoroquinolones

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What is this trial about?

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

This clinical trial is focused on studying the treatment of acute pyelonephritis, a type of kidney infection, in individuals who have received a kidney transplant. The study aims to determine if a 7-day course of antibiotics is as effective as a 14-day course in treating this condition. Participants in the trial will receive one of the following antibiotics: beta-lactam antibacterials, which include penicillins, sulfamethoxazole and trimethoprim, or fluoroquinolones. These medications are commonly used to treat bacterial infections.

The purpose of the study is to compare the effectiveness of the shorter and longer antibiotic treatments. Participants will be randomly assigned to receive either a 7-day or a 14-day course of antibiotics. The study will monitor the participants' health and recovery over a period of time to assess the effectiveness of the treatment. This will include checking for the resolution of symptoms such as fever and urinary tract infection signs, as well as ensuring no additional antibiotic treatment is needed up to 30 days after the initial treatment.

Throughout the study, participants will be observed for any potential side effects from the antibiotics and their overall kidney function will be assessed. The study will also track the incidence of any relapse or recurrence of the infection, as well as the presence of antibiotic-resistant bacteria. The goal is to ensure that the shorter treatment is not less effective than the longer one, potentially leading to a change in standard treatment practices for kidney transplant recipients with acute pyelonephritis.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed through written consent. Eligibility is based on being a kidney transplant recipient over 18 years old with acute pyelonephritis, characterized by fever and a positive urine culture.

    Initial assessments include checking for any other infections or complications and ensuring a positive response to initial antibiotic treatment.

  2. Step 2

    Antibiotic treatment

    The treatment involves taking antibiotics orally. The specific medication used is a combination of sulfamethoxazole and trimethoprim.

    The study compares two durations of antibiotic therapy: 7 days versus 14 days. The goal is to determine if the shorter treatment is as effective as the longer one.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring occurs to assess the response to treatment. This includes checking for a reduction in fever and improvement in symptoms.

    The primary evaluation takes place 30 days after the end of antibiotic treatment to confirm clinical cure, defined as no fever and absence of urinary symptoms.

  4. Step 4

    Follow-up assessments

    Further assessments are conducted at 90 and 180 days to ensure continued clinical and microbiological cure.

    Additional evaluations include monitoring kidney function, checking for any recurrence of infection, and assessing any adverse effects from the antibiotics.

  5. Step 5

    Completion of the study

    The study concludes with a final assessment of overall health and kidney function.

    The results contribute to understanding the optimal duration of antibiotic therapy for kidney transplant recipients with acute pyelonephritis.

Who can join the trial?

6 criteria

  • Must be over 18 years old and have received a kidney transplant.
  • Must have **acute pyelonephritis (APN)**, which is a kidney infection. This is defined by having a fever of 38°C or higher, with or without signs of a urinary tract infection (UTI), and having **pyuria**, which means having 10,000 or more white blood cells per milliliter of urine, or 10 or more per cubic millimeter. Additionally, there must be a positive urine culture showing bacteria that the given antibiotic can treat.
  • Must not have any other confirmed or suspected bacterial infection that causes fever and is not related to the urinary system.
  • Must not have any complications in the urinary or kidney area, such as an abscess or blockage, as shown in initial imaging tests.
  • Must show a positive early response to antibiotic treatment within 48 to 60 hours after the first dose. This means the fever should drop below 38°C, and any signs or symptoms of a urinary tract infection should improve or go away.
  • Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

2 criteria

  • Patients who have had a **kidney transplant** cannot participate. A kidney transplant is when a person receives a new kidney from a donor.
  • Patients with **pyelonephritis** cannot participate. Pyelonephritis is a type of kidney infection.
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Investigated drugs

Antibiotic Therapy This clinical trial is investigating the effectiveness of antibiotic therapy in treating acute pyelonephritis in kidney transplant recipients. The study compares two durations of antibiotic treatment: 7 days versus 14 days. The goal is to determine if a shorter course of antibiotics is as effective as the longer course in managing the infection.

What is already known about the treatment

Antibiotic Therapy – This medication is administered orally or intravenously, depending on the specific antibiotic used and the severity of the infection. It is currently being studied in clinical trials to determine the optimal duration of treatment for acute pyelonephritis in kidney transplant recipients. The main therapeutic indication is the treatment of bacterial infections, specifically targeting acute pyelonephritis. At the molecular level, antibiotics work by either killing bacteria or inhibiting their growth, often by interfering with bacterial cell wall synthesis or protein production. They are classified pharmacologically as antibacterial agents.

Investigated diseases

  • Pyelonephritis

    Pyelonephritis is a type of urinary tract infection that affects the kidneys. It usually begins as a bladder infection that spreads to the kidneys. Symptoms often include fever, chills, back or side pain, and frequent urination. If untreated, it can lead to more severe kidney issues. The condition can occur suddenly and may require medical attention to prevent complications. It is more common in women and can be recurrent in some individuals.

  • Kidney Transplant Recipients

    Kidney transplant recipients are individuals who have received a kidney from a donor to replace their own failing kidneys. After the transplant, they must take medications to prevent their immune system from rejecting the new organ. These individuals are at increased risk for infections, including urinary tract infections, due to immunosuppressive therapy. Monitoring and managing these infections are crucial to maintaining the health of the transplanted kidney. Regular follow-up and medical care are essential to ensure the transplant's success and the recipient's well-being.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513328-40-00Protocol codeAPHP200020Estimated enrolment470 patientsSponsorAssistance Publique Hopitaux De Paris

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