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.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Urology, Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Department of Urology, Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of Urology, Rigshospitalet
RECRUITING
Copenhagen
Department of Urology, Herlev and Gentofte Hospital
NOT_YET_RECRUITING
Herlev
Department of Urology, Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Maja Vejlgaard
maja.vejlgaard.02@regionh.dk
+4535456152
Time Frame
Start Date: 2025-01-07
Estimated Completion Date: 2027-01
Participants
Target number of participants: 248
Treatments
Experimental: Targeted antimicrobial prophylaxis
The participants in this arm will receive a single-day orally administered targeted antimicrobial prophylaxis on the day of ureteral stent removal based on the microbiological analysis of a postoperative urine culture.
Active_comparator: Empiric antimicrobial prophylaxis
The participants in this arm will receive three doses of orally administered pivmecillinam 400mg morning, noon, and evening on the day of ureteral stent removal.
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov