Tests targeted antibiotics to prevent infection after bladder removal surgery
Compares urine-targeted antibiotics with standard antibiotics in adults after bladder removal surgery.
Plain-language title generated from the registry record
Registry title: Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Herlev, and Odense, DenmarkSee the 5 sites
- Phase
- Phase 4
Where in Denmark
- Department of Urology, Aalborg University HospitalAalborg, DenmarkNot yet recruiting
- Department of Urology, Aarhus University HospitalAarhus, DenmarkNot yet recruiting
- Department of Urology, RigshospitaletCopenhagen, DenmarkTaking people
- Department of Urology, Herlev and Gentofte HospitalHerlev, DenmarkNot yet recruiting
- Department of Urology, Odense University HospitalOdense, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT06709196EU 2024-514312-27-00
- Record updated
- 9 January 2025
- Original description
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.Read full original descriptionShow less
REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.
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.
Inclusion: 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: Previous severe allergic reaction to antimicrobial treatment; Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy.