Testing targeted antibiotics to prevent infections after bladder surgery
Official title: 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.
Run by Copenhagen University Hospital, Rigshospitalet · NCT06709196 · Data updated 2026-11-12
This study is testing if using personalized antibiotics based on urine bacteria can help prevent infections after bladder surgery better than standard antibiotics.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 248 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | January 9, 2025 |
| Trial ID | NCT06709196 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled for cystectomy with an ileal conduit urinary diversion.
✕Probably not a fit
Patients with a history of severe allergic reactions to antibiotics or those on long-term prophylactic antibiotic treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to determine if using targeted antibiotics based on urine bacteria can lower the risk of infections following cystectomy compared to standard antibiotic prophylaxis. Participants will be randomly assigned to receive either a standardized antibiotic regimen or a targeted antibiotic treatment based on their urine culture results. The study seeks to address the high rate of infection-related readmissions after bladder surgery by evaluating the effectiveness of a more personalized antibiotic approach. The trial is multicenter and open-label, involving several hospitals in Denmark.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative infections and hospital readmissions for patients undergoing cystectomy.
How similar studies have gone: While there is limited high-evidence research on antibiotic prophylaxis after cystectomy, the study's targeted approach is innovative and may provide new insights into infection prevention.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Urology, Rigshospitalet
Copenhagen, Denmark Recruiting -
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, Herlev and Gentofte Hospital
Herlev, Denmark Not yet recruiting -
Department of Urology, Odense University Hospital
Odense, Denmark Not yet recruiting
Study contacts
- Principal investigator: Andreas Røder, Prof, MD, PhD — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Maja Vejlgaard
- Email: maja.vejlgaard.02@regionh.dk
- Phone: +4535456152
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.