Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Prophylaxis | — | UNRESOLVED | — |
| Bladder Cancer Requiring Cystectomy | — | UNRESOLVED | — |
| Cystectomy | — | UNRESOLVED | — |
| Ileal Conduit | — | UNRESOLVED | — |
| Postoperative Infections | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Amoxicillin clavulanic acid | Drug | — | UNRESOLVED |
| Cefuroxime | Drug | — | UNRESOLVED |
| Ciprofloxacin | Drug | — | UNRESOLVED |
| Fluconazole | Drug | — | UNRESOLVED |
| Linezolid | Drug | — | UNRESOLVED |
| Nitrofurantoin | Drug | — | UNRESOLVED |
| Pivmecillinam | Drug | — | UNRESOLVED |
| Sulfamethoxazole trimethoprim | Drug | — |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Targeted antimicrobial prophylaxis
- description
- 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.
- interventionNames
- Drug: Pivmecillinam
- Drug: Amoxicillin clavulanic acid
- Drug: Amoxicillin
- Drug: Cefuroxime
- Drug: Ciprofloxacin
- Drug: Linezolid
- Drug: Nitrofurantoin
- Drug: Trimethoprim
- Drug: Sulfamethoxazole trimethoprim
- Drug: Fluconazole
- type
- ACTIVE_COMPARATOR
- label
- Empiric antimicrobial prophylaxis
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVejlgaard M, Stroomberg HV, Ynddal MS, Moser C, Joensen UN, Roder A. Multicentre, open-label, phase IV, randomised trial testing superiority of individualised targeted antibiotic prophylaxis over empiric prophylaxis at ureteral stent removal following cystectomy: study protocol for the REINFORCE trial. Trials. 2025 Jul 28;26(1):258. doi: 10.1186/s13063-025-08981-w. PMID 40722189