NCT06709196RecruitingPhase 4
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
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.
Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 7 Jan 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Bladder cancer
- NCT number
- NCT06709196
- EU CT number
- 2024-514312-27-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 248
- From 7 Jan 2025 to the primary completion date, 31 Jan 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous severe allergic reaction to antimicrobial treatment
Other
- Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Department of Urology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Not yet recruiting |
| Department of Urology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Department of Urology, Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
| Department of Urology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.