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Taking people in DenmarkPhase 4

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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are having their bladder removed (cystectomy) with an ileal conduit. It tests whether antibiotics targeted to bacteria in the urine lower infections after surgery.

Age
18 years or older
Sex
All sexes can join
Disease stage
A cancer or non-cancer reason for bladder removal, with an ileal conduit planned to drain urine
Earlier treatment
Cannot join if on long-term preventive antibiotics that will continue after the surgery

Main reasons for not taking part

  • Past severe allergic reaction to antibiotic treatment
  • Long-term preventive antibiotics expected to continue after the surgery

Read by machine on 9 November 2026.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT06709196 · EU CTIS 2024-514312-27-00