Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Launched by RIGSHOSPITALET, DENMARK · Nov 27, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether using antibiotics specifically chosen based on the bacteria found in urine can help prevent infections after bladder removal surgery, known as cystectomy. Participants in the study will be randomly assigned to one of two groups: one group will receive a standard antibiotic that is usually given after surgery, while the other group will receive antibiotics that are tailored to the bacteria identified in their urine. Researchers hope that the targeted approach will lead to fewer patients needing to return to the hospital for infections within 90 days after their surgery.
To participate in this trial, individuals must be at least 18 years old and able to understand and sign consent forms. They should be having surgery for bladder cancer or other reasons that require cystectomy and will have an ileal conduit, which is a way to divert urine after the bladder is removed. Participants should be aware that those with a history of severe allergic reactions to antibiotics or who are on long-term antibiotic treatment may not be eligible for this study. Overall, this trial aims to improve post-surgical care and reduce the risk of infections for patients undergoing this significant procedure.
Gender
ALL
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
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Odense, , Denmark
Copenhagen, , Denmark
Aalborg, , Denmark
Aarhus, , Denmark
Herlev, , Denmark
Patients applied
Trial Officials
Andreas Røder, Prof, MD, PhD
Principal Investigator
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported