Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

NCT06709196 · tracked via the Priya Life Science Denmark tracker

Sponsor

Rigshospitalet, Denmark

Phase

Phase 4

Started

2025-01-07

Last updated

2025-01-09

Condition(s) studied

CystectomyBladder Cancer Requiring CystectomyPostoperative InfectionsAntibiotic ProphylaxisIleal Conduit

Investigational drug(s) / intervention(s)

Pivmecillinam →Pivmecillinam →Amoxicillin clavulanic acid →Amoxicillin →Cefuroxime →Ciprofloxacin →Linezolid →Nitrofurantoin →TrimethoprimSulfamethoxazole trimethoprimFluconazole →

Pivmecillinam: Orally administered pivmecillinam 400mg

Pivmecillinam: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Amoxicillin clavulanic acid: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Amoxicillin: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Cefuroxime: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Ciprofloxacin: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Linezolid: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Nitrofurantoin: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Trimethoprim: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Sulfamethoxazole trimethoprim: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Fluconazole: Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Study summary

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.

Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.

The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age at surgery ≥ 18 years * Ability to understand and sign an informed consent * Malignant or benign indication for undergoing cystectomy * Planned ileal conduit as urinary diversion Exclusion Criteria: * Previous severe allergic reaction to antimicrobial treatment * Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy

Primary outcome measure(s)

Infection-related readmission rate — 90 days after surgery
The rate of readmissions where the main cause of readmission is symptoms of infection.

Trial sites (5)

Facility	City	Region	Status
Department of Urology, Aalborg University Hospital	Aalborg	Denmark	Not Yet Recruiting
Department of Urology, Aarhus University Hospital	Aarhus	Denmark	Not Yet Recruiting
Department of Urology, Rigshospitalet	Copenhagen	Denmark	Recruiting
Department of Urology, Herlev and Gentofte Hospital	Herlev	Denmark	Not Yet Recruiting
Department of Urology, Odense University Hospital	Odense	Denmark	Not Yet Recruiting

On this site

📄 Amoxil (amoxicillin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06709196 on ClinicalTrials.gov ↗ ← All trials in Denmark