Study on Fluconazole and Sodium Chloride to Prevent Fungal Infections in Patients Undergoing Cystectomy

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What is this study about?

This clinical trial is focused on reducing complications after a surgical procedure called a cystectomy, which involves removing the bladder. The study is particularly interested in preventing complications caused by fungal infections. To achieve this, the trial will use a medication called Fluconazole, which is given as a solution through an intravenous infusion. This means the medicine is delivered directly into the bloodstream through a vein. The study will compare the effects of Fluconazole with a placebo to see if it can effectively reduce the risk of complications after surgery.

The main goal of the study is to determine if using Fluconazole as a preventive treatment can help reduce the number of complications that occur after a cystectomy. Participants in the study will receive either Fluconazole or a placebo during their treatment. The study will monitor various outcomes, such as the number of days participants are alive and out of the hospital within 90 days after surgery, the time it takes for their digestive system to start working again, and their overall quality of life. The study will also look at the length of hospital stay, the need for re-admission, and any infections that require treatment.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how well the treatment works. The trial is expected to continue until the end of 2026, with recruitment starting in early 2024. This research aims to provide valuable insights into improving recovery and reducing complications for patients undergoing cystectomy.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose and procedures. The patient must be over 18 years old, able to understand and sign an informed consent in Danish, and have an indication for cystectomy with urinary diversion limited to the ileal conduit.

2 preoperative phase

Before the surgery, the patient will receive detailed instructions about the trial and the medications involved. The patient will be randomly assigned to receive either the antifungal medication or a placebo.

3 medication administration

The patient will receive fluconazole as a 2 mg/ml solution for infusion or a placebo. This will be administered through an intravenous infusion. The exact dosage and frequency will be determined by the medical team based on the trial protocol.

4 surgery and immediate postoperative care

The patient will undergo cystectomy surgery. Postoperative care will include monitoring for any complications and ensuring recovery is on track. The medical team will assess the patient’s condition using the Clavien Dindo classification score.

5 postoperative monitoring

The patient’s recovery will be monitored for 90 days post-surgery. This includes tracking days alive and out of the hospital, time to first bowel movement, and any need for a nasogastric tube. Quality of life will be assessed using specific questionnaires at day 0 and day 90.

6 follow-up and evaluation

The patient will have follow-up appointments to evaluate recovery progress, including any urinary tract infections or microbiome resistance development. The length of hospital stay and any readmissions within 30 and 90 days will also be recorded.

Who Can Join the Study?

Patients must be older than 18 years.
Patients must be willing to participate in the study and able to understand and sign an informed consent form in Danish.
Patients must have a medical reason for needing a cystectomy. A cystectomy is a surgery to remove the bladder.
The type of urinary diversion, which is a way to reroute urine after bladder removal, must be limited to the ileal conduit. An ileal conduit is a small piece of the intestine used to create a new path for urine to leave the body.

Who Cannot Join the Study?

Patients with a fungal infection cannot participate. A fungal infection is when fungi, which are a type of germ, cause an infection in the body.
Patients who are not within the specified age range cannot participate. The age range for this study is not provided here.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who might be at higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Hjwbur Hltigrdk	Herlev	Denmark
Aplzqz Ueolvkwecs Hoofezcq	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	24.06.2024

Trial locations

Investigated drugs:

Prophylactic Antimycotic Medicine is used in this trial to prevent fungal infections that might occur after a surgical procedure called cystectomy. The goal is to see if this medication can help reduce complications that patients might experience after the surgery. This medicine is given to patients before and after the surgery to protect them from potential fungal infections, which can be a risk during the recovery period.

Investigated diseases:

Fungal infection

Fungal Infection – A fungal infection occurs when fungi invade and grow in or on the body, often affecting the skin, nails, or lungs. These infections can range from mild, such as athlete’s foot, to more severe forms like invasive candidiasis. Fungi thrive in warm, moist environments, and infections can spread through direct contact or inhalation of spores. Symptoms vary depending on the type and location of the infection but may include itching, redness, and discomfort. Some fungal infections can become chronic if not addressed, leading to persistent symptoms. The progression of the disease depends on the individual’s immune response and the specific type of fungus involved.

Trial ID:

2023-506226-36-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Fluconazole and Sodium Chloride to Prevent Fungal Infections in Patients Undergoing Cystectomy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?