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Study on the Effectiveness and Safety of Circumcision and Antibiotic Treatment (Cefaclor, Sulfamethoxazole, Trimethoprim) for Boys with Posterior Urethral Valves

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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 effects of circumcision on the risk of febrile urinary tract infections (fUTIs) in boys with a condition called Posterior Urethral Valves (PUV). PUV is a blockage in the urinary tract that occurs in boys and can lead to urinary problems. The study aims to understand how circumcision alone, as well as in combination with antibiotic treatments, affects the likelihood of developing fUTIs over a period of two years.

In this study, the medications being used include ALFATIL, which contains the active substance cefaclor, Bactrim, which contains sulfamethoxazole and trimethoprim, and AUGMENTIN, which contains amoxicillin and clavulanic acid. These medications are all antibiotics, which are drugs used to treat bacterial infections. The trial will compare the effects of circumcision alone, circumcision with antibiotics, and antibiotics alone on the risk of fUTIs.

The study will follow participants over a two-year period to observe the time it takes for the first fUTI to occur, if at all. It will also look at the number of infections, any changes in kidney health, and the types of bacteria causing the infections. The goal is to determine the best approach to reduce the risk of fUTIs in boys with PUV, using historical data to enrich the findings. Participants will be monitored for their adherence to the antibiotic treatments and the overall effectiveness of the different approaches will be assessed.

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, the child must be a male aged between 1 to 31 days. The child should have undergone a procedure called valve resection and circumcision before reaching one month of age.

    The child's guardians must be adults over 18 years old, affiliated with a social security system, and have signed an informed consent form allowing the child to participate in the study.

  2. Step 2

    Initial medical assessment

    The child will undergo an initial medical assessment to confirm the diagnosis of posterior urethral valves through a procedure called cystography, which should have been completed within the first 28 days of life.

  3. Step 3

    Treatment and monitoring

    The study aims to assess the effect of circumcision alone on the risk of febrile urinary tract infections (fUTIs) over a period of two years. The child may also receive antibiotic prophylaxis, which involves taking medication to prevent infections.

    The medications used in the study include cefaclor, sulfamethoxazole with trimethoprim, and amoxicillin with clavulanic acid. These are administered orally in the form of a suspension, which is a liquid form of medication.

  4. Step 4

    Follow-up and evaluation

    The primary goal is to monitor the time to the first febrile urinary tract infection from the start of the study until two years later. A febrile urinary tract infection is identified by a fever higher than 38.5 degrees Celsius, along with signs of infection in the urine.

    Secondary evaluations include the number of infections over two years, changes in kidney scans, and the types of germs causing infections. The study will also explore factors that may increase the risk of infections and adherence to antibiotic treatment.

  5. Step 5

    Completion of the study

    The study is expected to conclude by May 15, 2030. At the end of the study, the collected data will be analyzed to determine the effectiveness of circumcision alone, circumcision with antibiotics, and antibiotics alone in preventing febrile urinary tract infections.

Who can join the trial?

9 criteria

  • The child must be a male.
  • The child must be between 1 to 31 days old.
  • The child must have had a procedure called valve resection and circumcision before they are 1 month old.
  • The child must have been diagnosed with Posterior Urethral Valves using a test called cystography within the first 28 days of life.
  • The child's parental guardians must be over 18 years old.
  • The child's parental guardians must be part of a social security system.
  • The child's parental guardians must have signed an informed consent form, which means they agree to let their child participate in the study.
  • For some groups, the child's parental guardians must not be opposed to their child's participation in the trial.
  • The child's parental guardians giving consent must be able to understand the trial completely.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The study is for children only.
  • Patients who do not have Posterior Urethral Valves cannot participate. This is a condition affecting the urinary tract.
  • Patients who are considered part of a vulnerable population may not be eligible. This means groups who might need special protection or care.
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Investigated drugs

Antibiotic Prophylaxis is a treatment approach where antibiotics are given to prevent infections before they occur. In this trial, the focus is on preventing febrile urinary tract infections in boys with a specific condition called posterior urethral valves. The antibiotics work by stopping bacteria from growing and causing an infection, which can help reduce the risk of these infections happening in the first place.

What is already known about the treatment

Circumcision – Circumcision is a surgical procedure that involves the removal of the foreskin from the penis. In the context of this clinical trial, it is being studied for its potential to reduce the risk of febrile urinary tract infections (fUTIs) in boys with a condition called posterior urethral valves (PUV). The trial aims to evaluate the effectiveness of circumcision alone, as well as in combination with antibiotic prophylaxis, compared to antibiotic prophylaxis alone. Circumcision is not a medication but a surgical intervention, and it is being explored for its therapeutic benefits in preventing infections in this specific patient group.

Investigated diseases

Posterior Urethral Valves – Posterior Urethral Valves is a condition characterized by the presence of abnormal folds of tissue in the urethra of male infants, which obstructs the normal flow of urine. This obstruction can lead to a buildup of urine in the bladder, ureters, and kidneys, causing swelling and potential damage. Over time, the increased pressure can result in bladder dysfunction and kidney impairment. The condition is typically identified in infancy or early childhood. As the child grows, the severity of symptoms can vary, potentially leading to urinary tract infections and issues with kidney function. Regular monitoring and management are essential to address complications associated with this condition.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-519166-48-01Protocol codeCHUBX 2023/52Estimated enrolment163 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

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