Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Recruiting
Phase 4
Interventional Study
Cystectomy
Bladder Cancer Requiring Cystectomy
Postoperative Infections
Antibiotic Prophylaxis
Ileal Conduit
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 248 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Other
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About This Trial
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 currentl…
Trial Locations
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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-te…
Contacts