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RECRUITING
NCT06709196
PHASE4

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2025-01-07

Completion Date

2027-01

Last Updated

2025-01-09

Healthy Volunteers

No

Interventions

DRUG

Pivmecillinam

Orally administered pivmecillinam 400mg

DRUG

Pivmecillinam

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Amoxicillin clavulanic acid

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Amoxicillin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Cefuroxime

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Ciprofloxacin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Linezolid

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Nitrofurantoin

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Trimethoprim

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Sulfamethoxazole trimethoprim

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

DRUG

Fluconazole

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Locations (5)

Department of Urology, Aalborg University Hospital

Aalborg, Denmark

Department of Urology, Aarhus University Hospital

Aarhus, Denmark

Department of Urology, Rigshospitalet

Copenhagen, Denmark

Department of Urology, Herlev and Gentofte Hospital

Herlev, Denmark

Department of Urology, Odense University Hospital

Odense, Denmark