Testing targeted antibiotics to prevent infections after bladder surgery
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.
PHASE4 · Rigshospitalet, Denmark · NCT06709196
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT06709196 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for cystectomy with an ileal conduit urinary diversion.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aalborg and 4 other locations
- 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, Rigshospitalet — Copenhagen, Denmark (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 — Rigshospitalet, Denmark
- Study coordinator: Maja Vejlgaard
- Email: maja.vejlgaard.02@regionh.dk
- Phone: +4535456152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystectomy, Bladder Cancer Requiring Cystectomy, Postoperative Infections, Antibiotic Prophylaxis, Ileal Conduit, Targeted antimicrobial prophylaxis, Infection-related readmissions