NCT06709196 Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
| NCT ID | NCT06709196 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cystectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 248 participants in total. It began in 2025-01-07 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Andreas Røder, Prof, MD, PhD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06709196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06709196 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06709196 currently recruiting?
Yes, NCT06709196 is actively recruiting participants. Contact the research team at maja.vejlgaard.02@regionh.dk for enrollment information.
Where is the NCT06709196 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Herlev, Denmark and 1 additional location.
Who is sponsoring the NCT06709196 clinical trial?
NCT06709196 is sponsored by Rigshospitalet, Denmark. The principal investigator is Andreas Røder, Prof, MD, PhD at Rigshospitalet, Denmark. The trial plans to enroll 248 participants.