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Study on Reducing Infections After Bladder Removal Surgery Using Pivmecillinam Hydrochloride and Other Antibiotics for Patients Undergoing Ureteral Stent Removal

Verified siteRegistered drugNo placebo

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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 reducing infection-related hospital readmissions after a surgical procedure called a cystectomy, which involves removing the bladder. The study is investigating the effectiveness of using specific antibiotics tailored to individual needs, known as targeted antibiotic prophylaxis, compared to the usual practice of giving general antibiotics, called empiric prophylaxis, during the removal of a ureteral stent. A ureteral stent is a small tube placed in the ureter to help urine flow from the kidney to the bladder. The main goal is to see if the targeted approach can better prevent infections that lead to hospital readmissions.

The trial involves several medications, including Pivmecillinam hydrochloride, Trimethoprim, Fluconazole, Amoxicillin, Ciprofloxacin, Sulfamethoxazole with Trimethoprim, Amoxicillin with Clavulanic acid, Cefuroxime axetil, Nitrofurantoin, and Linezolid. These medications are being tested to determine their effectiveness in preventing infections after the surgery. Some participants will receive these medications, while others may receive a placebo. The study aims to find the best way to prevent infections and improve recovery after a cystectomy.

Participants in the study will undergo the cystectomy procedure and then be monitored for any signs of infection. The study will track the rate of hospital readmissions due to infections within 90 days after the surgery. It will also look at other factors, such as the timing of stent removal, any complications after surgery, and the overall quality of life of the participants. The study is expected to continue until 2027, with the goal of improving care and outcomes for patients undergoing cystectomy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You must meet certain criteria, such as being 18 years or older and having undergone a cystectomy, which is a surgery to remove the bladder.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline information. This may include medical history, current health status, and any medications you are taking.
Step 3
Ureteral stent removal
During the study, you will undergo ureteral stent removal. A ureteral stent is a small tube placed in the ureter to help urine flow from the kidney to the bladder.
At the time of stent removal, you will receive either the standard antibiotic treatment or a targeted antibiotic prophylaxis. This is to prevent infections after the procedure.
Step 4
Medication administration
You will be given one of the following medications orally: pivmecillinam hydrochloride, trimethoprim, fluconazole, amoxicillin, ciprofloxacin, sulfamethoxazole with trimethoprim, amoxicillin with clavulanic acid, cefuroxime axetil, nitrofurantoin, or linezolid.
The specific medication, dosage, and duration will be determined based on your individual needs and the study protocol.
Step 5
Follow-up assessments
You will have follow-up assessments to monitor your health and any potential infections. These assessments will occur at various intervals, such as 30 and 90 days after surgery.
During these assessments, you may be asked to complete questionnaires about your quality of life and undergo microbiological tests to check for infections.
Step 6
Completion of the study
At the end of the study period, your participation will conclude. You will have a final assessment to review your health status and any outcomes related to the study.

Who can join the trial?

4 criteria

Must be at least 18 years old at the time of surgery.
Must be able to understand and sign a document that explains the study and gives permission to participate, known as an informed consent.
Must be undergoing a surgery called cystectomy, which is the removal of the bladder, for either cancerous (malignant) or non-cancerous (benign) reasons.
Must have a planned procedure called an ileal conduit, which is a way to reroute urine after the bladder is removed.

Who cannot join the trial?

3 criteria

Patients with any **bacterial infection** cannot participate. A bacterial infection is when harmful bacteria enter the body and cause illness.
Patients who are not within the specified **age range** cannot participate. The study is open to certain age groups only.
Patients who are part of a **vulnerable population** cannot participate. This means people who might need special protection or care.

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Verified sites

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Aalborg University Hospital
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Aalborg, Denmark
Herlev Hospital
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Herlev, Denmark
Odense University Hospital
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Odense, Denmark

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Investigated drugs

Targeted Antibiotic Prophylaxis
is a treatment approach where specific antibiotics are chosen based on the individual patient's needs and the specific bacteria that might cause an infection. This method aims to prevent infections more effectively by using antibiotics that are most likely to work against the bacteria present in the patient. In this trial, the goal is to see if using targeted antibiotics can reduce the number of hospital readmissions due to infections after a surgical procedure called cystectomy.
Empiric Antibiotic Prophylaxis
is a standard treatment where antibiotics are given based on general guidelines rather than specific patient needs. This approach uses a broad-spectrum antibiotic that can target a wide range of bacteria, even if the exact bacteria causing the infection are not known. The trial is comparing this method to targeted antibiotic prophylaxis to see which one is more effective in preventing infections after cystectomy.

What is already known about the treatment

Targeted Antibiotic Prophylaxis – This medication is administered orally or intravenously, depending on the specific antibiotic used, and is applied as a preventive measure to reduce infections. Currently, it is being studied in clinical trials to determine its effectiveness in reducing infection-related hospital readmissions after bladder surgery, specifically cystectomy. The main therapeutic indication is to prevent bacterial infections that can occur after surgical procedures. At the molecular level, antibiotics work by targeting and killing bacteria or inhibiting their growth, which helps prevent infections. This medication falls under the pharmacological classification of antibiotics, which are drugs used to treat bacterial infections.

Investigated diseases

Bacterial infection – Bacterial infection occurs when harmful bacteria enter the body and begin to multiply. These bacteria can invade tissues and release toxins, leading to symptoms such as fever, inflammation, and pain. The progression of a bacterial infection depends on the type of bacteria and the body's immune response. In some cases, the infection may remain localized, while in others, it can spread to other parts of the body. If the immune system is unable to control the infection, it may lead to more severe symptoms and complications. The body's response to bacterial infection can vary, and the infection may resolve on its own or require medical intervention.